FDA Adverse Event
Death
Summary report: N
INVACARE RELIANT 450
MDR report key: 4231618
·
Received October 31, 2014
Report
- Report Number
- MW5038953
- Event Type
- Death
- Date Received
- October 31, 2014
- Date of Event
- October 30, 2014
- Report Date
- October 31, 2014
- Manufacturer
- INVACARE CORPORATION
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE LOCKNUT USED TO ATTACH THE SCALE AND THE SWIVEL BAR TO THE BOOM OF THE LIFT FELL OFF CAUSING THE BOLT TO BE DISASSEMBLED DURING A TRANSFER OF A RESIDENT. THE RESIDENT FELL TO THE FLOOR AND THE SWIVEL BAR AND SCALE LANDED ON HER CHEST. THE LIFT HAD BEEN USED LESS THAN ONE YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 698323 | INVACARE RELIANT 450 | SLING LIFT | FNG | INVACARE CORPORATION | RPL 450-I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 97 YR | Death |