FDA Adverse Event
Malfunction
Summary report: N
AMBULIFT BSQ
MDR report key: 352559
·
Received September 21, 2001
Report
- Report Number
- 9617021-2001-00133
- Event Type
- Malfunction
- Date Received
- September 21, 2001
- Date of Event
- June 29, 2001
- Report Date
- August 13, 2001
- Manufacturer
- ARJO, LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE FACILITY REPORTS AFTER WASHING THE RESIDENT THE NURSE HAD TO GO OUT OF THE BATH. THE UNDERCARRIAGE WAS PLACED UNDER THE LIFT AND THE RESIDENT FELL. THE DEVICE WAS FOUND TO BE OKAY AFTER EXAMINATION AND NO INJURIES WERE SUSTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43202 | AMBULIFT BSQ | PATIENT LIFT | FSA | ARJO, LTD. | ABXXXX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |