FDA Adverse Event
Malfunction
Summary report: N
AMBULIFT (MANUAL)
MDR report key: 4843961
·
Received June 12, 2015
Report
- Report Number
- 3007420694-2015-00114
- Event Type
- Malfunction
- Date Received
- June 12, 2015
- Date of Event
- May 13, 2015
- Report Date
- May 14, 2015
- Manufacturer
- ARJO MED AB LTD
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INITIALLY IT WAS REPORTED BY ARJOHUNTLEIGH REP THAT THE RESIDENT FELL TO THE FLOOR DURING USE OF A DEVICE. THE RESIDENT WAS ON THE SEAT BEING MOVED OVER THE EDGE OF THE BATH WHEN THE SEAT FELL AWAY AND DROPPED ABOUT 18 INCHES TO THE FLOOR. SHE WAS CHECKED MEDICALLY AND APPEARED TO NOT HAVE SUSTAINED ANY INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383606 | AMBULIFT (MANUAL) | FSA | ARJO MED AB LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |