FDA Adverse Event
Malfunction
Summary report: N
837- KIN AIR MED SURGE PULSE
MDR report key: 2192391
·
Received August 1, 2011
Report
- Report Number
- 2192391
- Event Type
- Malfunction
- Date Received
- August 1, 2011
- Date of Event
- July 8, 2011
- Report Date
- August 1, 2011
- Manufacturer
- KCI
- Product Code
- INX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MOVING PATIENT FROM BED TO STRETCHER, WHEELS WERE LOCKED, BED MOVED. STAFF HAD TO HOLD AND LIFT PATIENT ONTO STRETCHER TO PREVENT A FALL.THIS WAS A RENTAL BED. BIOMED WAS ABLE TO RECREATE THE REPORTED PROBLEM. THIS IS RELATED TO USE ERROR. POTENTIAL FOR HARM. -THE WHEEL CASTER LOCKING MECHANISM CAN BE MISLEADING TO USERS BY PROVIDING A FALSE PERCEPTION OF BED BEING LOCKED IN PLACE. - WHEEL CASTERS DO NOT LOCK IN ALL POSITIONS. APPEARS THEY LOCK IN A FRONT OR BACK POSITION, I.E LINEAR FASHION ONLY
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 837- KIN AIR MED SURGE PULSE | BED - SPECIALTY | INX | KCI | 837- KIN AIR MED SURGE PULSE | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |