FDA Adverse Event
Malfunction
Summary report: N
MAXI MOVE
MDR report key: 3771241
·
Received January 14, 2014
Report
- Report Number
- 1419652-2014-00013
- Event Type
- Malfunction
- Date Received
- January 14, 2014
- Report Date
- December 30, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING TRANSFER BETWEEN CHAIR TO BED, PATIENT WAS UP ON HER BED IN THE SLING. THE ACTUATOR OF THE POWERED DPS HAD SUDDENLY EXTENDED WITHOUT REASON. THIS MOVEMENT HAD CAUSED THE UNLOCK OF CLIP SLING. PATIENT WAS LEANED AGAINST HER BED DURING INCIDENT AND FELL ON THE BED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37908 | MAXI MOVE | FSA | ARJOHUNTLEIGH MAGOG INC | KMCSXN-D-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |