FDA Adverse Event
Malfunction
Summary report: N
MAXI MOVE
MDR report key: 2994168
·
Received March 4, 2013
Report
- Report Number
- 9611530-2013-00019
- Event Type
- Malfunction
- Date Received
- March 4, 2013
- Date of Event
- February 3, 2013
- Report Date
- February 6, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJO HOSPITAL (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
DURING A CLIENT TRANSFER TO A WHEELCHAIR, THE LIFT ARM OF A PASSIVE FLOOR LIFT KEPT LOWERING EVEN IF THE HANDSET BUTTON WAS RELEASED. AFTER REMOVING THE LIFT FROM THE WHEELCHAIR, THE LIFT GOT DOWN UNTIL THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90933 | MAXI MOVE | PASSIVE FLOOR LIFTS | FSA | ARJO HOSPITAL EQUIPMENT AB | KMBB4HSX2FEU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |