Aquatec Ocean VIP mobile shower and toilet commode
Consumers, health professionals and health facilities are advised that Invacare Australia, in consultation with the TGA, is undertaking a recall for product correction of some units of its Aquatec Ocean VIP mobile shower and toilet commode due to an issue with the snap-on connectors that secure the backrest cushion (see accompanying photograph).
Invacare has advised that a problem with the injection moulding has led to some connectors being produced that do not meet design specification. These connectors may pull apart under less-than-acceptable force when the unit is in the reclined position.
Invacare Australia dealers will replace the connectors on all affected commodes.
The serial numbers of affected units in Australia are:
| 14547050 | 14547263 | 14547308 | 14547245 |
| 14547048 | 14547307 | 14547337 | 14547244 |
| 14547298 | 14547336 | 14547223 | 14547297 |
| 14547335 | 14547115 | 14547268 | 14547334 |
| 14547051 | 14547265 | 14547310 | 14547338 |
| 14547270 | 14547344 | 14547277 | 14547226 |
| 14547313 | 14547238 | 14547333 | 14547269 |
| 14547343 | 14547276 | 14547347 | 14547311 |
| 14547236 | 14547322 | 14547342 | 14547275 |
| 14547346 | 14547229 | 14547314 | 14547243 |
| 14547347 |
Information for consumers
Invacare Australia has written to distributors requesting that they contact all affected users and arrange for replacement of the snap-on connectors.
Users and carers should check the serial number of their commode against the list of serial numbers listed above to see if it is part of the recall for product correction.
If you think you or someone you care for has an affected commode and you have not been contacted, contact the dealer who supplied your commode. If you have any difficulties contacting the dealer, call Invacare Australia on 1800 460 460 (8am-5pm Monday-Friday).
Do not use affected commodes unless there is no alternative available. Be alert to the potential for failure of the snap-on connectors.
If you have any questions or concerns about this issue, contact the dealer who supplied your commode or call 1800 460 460.
Information for health professionals and health facilities
Invacare Australia has written to distributors requesting that they contact all affected users and arrange for replacement of the snap-on connectors.
If you are responsible for an Aquatec Ocean VIP mobile shower and toilet commode you should check the serial number against the list in the section above. If you have an affected commode, contact the dealer who supplied it for replacement of the connectors. If you have any difficulties contacting the dealer, call Invacare Australia on 1800 460 460 (8am-5pm Monday-Friday).
If you are treating a patient who uses an affected Aquatec Ocean VIP mobile shower and toilet commode, please make sure they or their carer are aware of this issue.
If they have not been contacted by Invacare Australia, advise them to check the serial number and, if affected, to contact the dealer who supplied their commode for replacement of the connectors. If they have any difficulties contacting the dealer, advise them to call Invacare Australia on 1800 460 460 (8am-5pm Monday-Friday).
Affected commodes should not be used until the connectors are replaced, unless there is no alternative available, and users should be alert to the potential for failure of the snap-on connectors.
If you have any questions or concerns about this issue, contact the dealer who supplied the commode or call 1800 460 460.
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).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.