FDA Adverse Event
Malfunction
Summary report: N
POWER LIFT W/LOW BASE-PLUS 9153633519
MDR report key: 4942850
·
Received July 27, 2015
Report
- Report Number
- 9616091-2015-01910
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Report Date
- July 29, 2015
- Manufacturer
- INVAMEX
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY THE RETURNS DEPARTMENT WHICH FOUND THAT THE SHOULDER SCREW THAT ATTACHES THE HANDLE MOUNTING BRACKET TO THE CROSS SUPPORT HAS COME LOOSE/OUT.
Description of Event or Problem · 1
THE BOLT IN THE BASE KEEPS BACKING ITS WAY OUT AS THE SPRING COMPRESSES.
Description of Event or Problem · 1
THE BOLT IN THE BASE KEEPS BACKING ITS WAY OUT AS THE SPRING COMPRESSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487621 | POWER LIFT W/LOW BASE-PLUS 9153633519 | LIFT, PATIENT, NON-AC-POWERED | FSA | INVAMEX | RPL450-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |