FDA Adverse Event
Malfunction
Summary report: N
MAXI MOVE
MDR report key: 3221014
·
Received July 5, 2013
Report
- Report Number
- 1419652-2013-00180
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- May 25, 2013
- Report Date
- June 17, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
WHILE SETTING UP THE MAXIMOVE FLOOR LIFT FOR A TRANSFER, BEFORE ATTACHING THE SLING, THE NURSE BELIEVED THAT THE HANGER BAR WAS LOOSE AND SHOOK THE UNIT (DESCRIBED TO BE A SLIGHT SHAKING). THIS CAUSED THE HANGER BAR ASSEMBLY TO FALL TO THE FLOOR. NO PT INVOLVED. REF MFR REPORT 9611530-2013-00072.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308185 | MAXI MOVE | FSA | ARJO HOSPITAL EQUIPMENT AB | KMBB4OLU2FUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |