FDA Adverse Event
Malfunction
Summary report: N
BATHLIFT BLISS RECLINER US AB
MDR report key: 3142163
·
Received May 23, 2013
Report
- Report Number
- 3005536958-2013-00016
- Event Type
- Malfunction
- Date Received
- May 23, 2013
- Date of Event
- March 1, 2013
- Report Date
- May 22, 2013
- Manufacturer
- HANDICARE
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE BATHLIFT WAS USED BY THE CUSTOMER IN THE TUB. THE BATHLIFT OPERATED CORRECTLY LOWERING INTO THE TUB BY DEPRESSING THE DOWN BUTTON ON THE HAND CONTROL. WHEN REQUIRED TO RISE UP OUT OF THE TUB THROUGH OPERATION OF THE UP BUTTON ON THE HAND CONTROL THE BATHLIFT WOULD NOT OPERATE. THE CUSTOMER WAS ABLE TO GET OUT OF THE TUB AND NO INJURIES WERE REPORTED AS A RESULT OF THE FAILURE. THE HANDSET HAS CURRENTLY BEEN RECALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229294 | BATHLIFT BLISS RECLINER US AB | BATHLIFT, 311 | FSA | HANDICARE | 311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |