FDA Adverse Event
Malfunction
Summary report: N
MAXI MOVE
MDR report key: 2223479
·
Received June 30, 2011
Report
- Report Number
- 9681684-2011-00051
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 1, 2011
- Manufacturer
- BHM MEDICAL INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
THE PT WAS BEING LIFTED FROM A WHEELCHAIR, JUST SLIGHTLY ABOVE THE CHAIR, THEN MOVED AWAY FROM THE CHAIR. AT THIS POINT, THE CARETAKER USED THE TILT OF THE SPREADER BAR AND THE RIGHT LEG SLING CLIP DETACHED. THE PT FELL TO THE FLOOR AND WAS THEN TAKEN TO THE HOSPITAL TO BE CHECKED FOR INJURIES, BUT NO ADDITIONAL DETAILS WERE RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI MOVE | MANUFACTURED FLOOR PASSIVE LIFT | FSA | BHM MEDICAL INC. | KMCLUN-D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O |