Puritan Bennett 980 Series Ventilator suspension revoked

The decision to suspend the PB980 ventilator from the Australian Register of Therapeutic Goods (ARTG) has been revoked. This revocation has occurred following review, by the Therapeutic Goods Administration's (TGA), of an application for revocation of the suspension from the sponsor, Medtronic.

The TGA is also imposing conditions on the inclusion of the PB980 ventilator in the ARTG, which will come into effect on 21 September 2018. Details of those conditions are provided below.

The suspension has been revoked because Medtronic has produced a software update for the PB980 ventilator (Maintenance Release 5.4) to address the Graphic User Interface malfunctions. This can only be confirmed through close and ongoing monitoring during clinical use. Medtronic have also amended the presentation of the scalar waveforms. The TGA is satisfied that the combination of Maintenance Release 5.4 and the imposed conditions reduces the risks sufficiently to warrant lifting the suspension.

New conditions of inclusion in the ARTG

Condition 1

Medtronic shall amend the wording of 2.10.2 GUI Touch Screen Reset at page 2-17 and 2-18 of the draft Operator's Manual (P/N 00070954, Rev.D) submitted on 17 July 2018 to the satisfaction of the TGA.

The heading of 2.10.2 should be revised to read GUI Touch Screen Unresponsive or Blank and Recommended Responses.

The wording of 2.10.2 should be revised to read:

"Rarely the graphical user interface (GUI) display (LCD panel) may become blank, cannot be read or becomes unresponsive. Audible and visual alarm functions are maintained and may be activated, and ventilation should continue as set."

In these conditions, first assess the patient, including an examination of the patient and a review of the monitored parameters, to confirm ventilation is in progress and to confirm the patient's status. Examine the status display on top of the breath delivery unit (BDU) to confirm ventilator function.

If, in your clinical judgement, the patient's status is satisfactory, and ventilation is continuing as set, follow the steps below for each specific GUI condition.

Note:

If, in your clinical judgement, the patient's status is unsatisfactory, consider patient transfer to another ventilator or provide alternate source of ventilation in accordance with your institution's protocols.

The ventilator should be replaced as soon as possible and repaired by qualified service personnel.

Specific GUI Conditions (Unresponsive or Blank) and Recommended Responses

1. Unresponsive screen with display still visible and waveforms active: If you observe an unresponsive GUI, inaccurate GUI responses, or unintended GUI responses, reset the touch screen to restore proper touch screen functionality [Page 2-18].
   
2. Momentary Blank GUI Screen / GUI Transient Reset: Rarely, the GUI resets spontaneously to ensure proper function. If this occurs, the status display shows a count-down timer until completion of the reset (see Table 2-9 on page 2-35, and illustration below). Assess the patient as described above and wait for the GUI reset to finish (approximately 30 seconds).
   
3. Blank GUI Screen / GUI Failure: An error message will be displayed on the status display (See Table 2-9 on page 2-15, and illustration below). If this occurs, confirm that ventilation continues as set, provide alternate ventilatory support or transfer the patient to another ventilator in accordance with your institution's protocols as soon as it is appropriate to do so. Service the ventilator prior to returning it for use on patients.
   

If the GUI condition is not remedied, consider patient transfer to another ventilator or provide alternate source of ventilation in accordance with your institution's protocols. Service the ventilator prior to returning it for use on patients.

Condition 2

Medtronic shall amend the wording of the Warning at page 1-6 of the draft Operator's Manual (P/N 00070954, Rev.D submitted on 17 July 2018 to the satisfaction of the TGA.

The Warning should be revised to read:

If the graphical user interface (GUI) display (LCD panel) is blank, experiences interference and cannot be read or is unresponsive, check the patient and then verify via patient observation and the status display that ventilation is continuing as set. See instructions at 2.10.2 GUI Touch Screen Unresponsive or Blank and Recommended Responses. Note that in some circumstances it may be necessary to transfer the patient to an alternative source of ventilation in accordance with your institution's protocol.

Condition 3

Medtronic shall insert in the list of General Warnings immediately following the Warning on page 1-6 concerning issues with the graphical user interface (GUI) display a new Warning with the symbol and the following wording:

Condition 4

Medtronic within two weeks of making the amendments described in Conditions 1, 2 and 3 above shall adopt the draft Operator's Manual Revision E (Part No. PT00070954E 2018-08) as the operative version for Australia and shall distribute the document to all users of the PB980 ventilator in Australia.

Condition 5

Medtronic within one month of the date of this decision letter coming into effect shall ensure the attachment next to the Status Display of the BDU of all PB980 ventilators:

1. that have been distributed in Australia to date; and
2. that may be distributed in Australia from the date of this notice,

of an adherent sticker with the clearly visible wording "IMPORTANT. Before use, read 2.10.2 of the Operator's Manual." The sticker and any alternative notice proposed by Medtronic must be approved by the TGA before implementation.

Condition 6

Medtronic shall conduct a programme of education directed at the medical and nursing staff of Intensive Care Units and at the senior biomedical engineers of all Australian institutions where PB980 ventilators have been installed. The programme must highlight the possibility and associated risks of the graphical user interface (GUI) display (LCD panel) on occasions becoming blank, experiencing interference and being unable to be read or becoming unresponsive and the steps to be taken as set out in 2.10.2 of the Operator's Manual. The programme must also include an explanation of the functions and limitations of the scalar waveforms and invite and encourage the reporting of all instances of the full intended functionality of the GUI unit of a PB 980 ventilator being partially or completely lost either temporarily or permanently to Medtronic. The TGA shall be given an opportunity to comment on the proposed programme before it is implemented.

Condition 7

Medtronic shall take all reasonable steps to collect detailed information about clinical events that are the subject of complaints and reports. Such information may include, where available, the actual versions of hardware and software of the ventilator, the age of the ventilator, the number of patients for whom it has been used and the number of hours it has been used since new or since servicing by qualified service personnel and the duration of prior ventilation of the patient to whom the event occurred. Such information may also include, where available, the age of the patient, the primary reason for ventilation and the outcome to the patient of the event.

Condition 8

Concerning all complaints or reports of occurrences in Australia of the graphical user interface (GUI) display (LCD panel) becoming blank, experiencing interference and being unable to be read or becoming unresponsive or otherwise describing or mentioning that the full intended functionality of the GUI unit of a PB 980 ventilator was partially or completely lost either temporarily or permanently, Medtronic shall within fifteen calendar days of a member of its staff receiving the complaint or report provide to the TGA all details of that information.

Concerning all complaints or reports of occurrences in all other countries of the graphical user interface (GUI) display (LCD panel) becoming blank, experiencing interference and being unable to be read or becoming unresponsive or otherwise describing or mentioning that the full intended functionality of the GUI unit of a PB 980 ventilator was partially or completely lost either temporarily or permanently, Medtronic shall for a period of twelve(12) months from the date these conditions take effect provide in a monthly report to the TGA full details of that information.

Concerning all complaints and reports, whether about such occurrences in Australia or another country, Medtronic shall subsequently send all other information as required under Australian legislation and may send updates to that information and comments about that information as it sees fit and at intervals of its choosing. The exemptions from reporting adverse events to the TGA set out at pages 302 to 305 of the Australian Regulatory Guidelines for Medical Devices (ARGMD) version 1.1., May 2011 shall not apply to this condition.

Condition 9

Medtronic shall provide to the TGA within two calendar months of it being signed by the principal investigator (s) the final study report of the prospective clinical study described at 4.2.1 of Post Market Clinical Follow-up Plan Puritan Bennett™ 980 Ventilator System DOC#RE00125018 Revision C submitted to TGA on 20 July 2018. The study should be limited to subjects ventilated with the PB980 ventilator system fitted with maintenance release 5.3 software or higher and the planned recruitment should be sufficient to ensure that there will be no fewer than 150 evaluable subjects.

Information for consumers

PB980 ventilators are used only in intensive care units and other high-level care wards within hospitals.

If you or someone you provide care for is hospitalised and needs mechanical ventilation, please be aware that the health professionals who work in these areas are highly trained and have protocols to deal with the potential issues that may affect these devices.

If you have any questions or concerns about this issue, speak to the hospital staff.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).