FDA Adverse Event
Malfunction
Summary report: N
PATIENT LIFT
MDR report key: 16519402
·
Received March 9, 2023
Report
- Report Number
- 3009402404-2023-00007
- Event Type
- Malfunction
- Date Received
- March 9, 2023
- Report Date
- March 8, 2023
- Manufacturer
- APEX HEALTHCARE MFG. INC
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT OR OTHER INFORMTION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
Description of Event or Problem · 0
IT WAS REPORTED TO THE MANUFACTURER, BY THE END USER, PER THE END USER, THAT ARM OF LIFT BROKE WHILE LIFTING RESIDENT, RESULTING IN A FALL. COMPLAINT #(B)(4) WAS ENTERED INTO OUR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436314 | PATIENT LIFT | FSA | APEX HEALTHCARE MFG. INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |