FDA Adverse Event
Death
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 2884516
·
Received December 22, 2012
Report
- Report Number
- 3004493922-2012-00756
- Event Type
- Death
- Date Received
- December 22, 2012
- Date of Event
- November 12, 2012
- Report Date
- December 21, 2012
- Manufacturer
- INVACARE SUZHOU
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
MDR DECISION DATE: (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
MDR DECISION DATE: (B)(4). SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES THAT HOSPICE STATED THAT DURING PATIENT TRANSPORT, THE FRONT CASTER LOCKED UP CAUSING THE LIFT TO FLIP OVER. ALLEGEDLY, AS A RESULT, THE PATIENT BROKE A FEMUR, BECAME BED BOUND AND DIED ONE WEEK LATER. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | INVACARE SUZHOU | 9805P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 | Death |