FDA Adverse Event
Malfunction
Summary report: N
NON AC-POWERED PATIENT LIFT
MDR report key: 3171345
·
Received June 14, 2013
Report
- Report Number
- 1525712-2013-04704
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Report Date
- May 20, 2013
- Manufacturer
- UNKNOWN
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT FALL OUT OF THE SLING AND ONTO THE FLOOR. NO MEDICAL INTERVENTION ALLEGED.
Description of Event or Problem · 1
PER THE PROVIDER THE STITCHING AT THE V POINT WHERE THEY MEET THE STITCHING ON ONE OF THE STRAPS CAME APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271915 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | UNKNOWN | 9805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |