FDA Adverse Event
Malfunction
Summary report: N
MAXISKY 600
MDR report key: 3771242
·
Received January 14, 2014
Report
- Report Number
- 1419652-2014-00012
- Event Type
- Malfunction
- Date Received
- January 14, 2014
- Date of Event
- December 31, 2013
- Report Date
- January 2, 2014
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TWO STAFF MEMBERS WERE TRANSFERRING CLIENT FROM THE BED TO A CHAIR. THE SLING WAS SET IN PLACE AND ATTACHED TO THE CEILING LIFT 4 POINT SPREADER BAR. WHEN LIFTING THE CLIENT UP AT APPROXIMATELY 12 INCHES OFF THE BED, THE RING PIN CAME OFF THE PIN AND THE SPREADER BAR DROPPED, FROM THE STRAP. CLIENT DROPPED SAFELY TO THE BED WITH NO INJURIES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37906 | MAXISKY 600 | FSA | ARJOHUNTLEIGH MAGOG INC | LD10001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |