FDA Adverse Event
Malfunction
Summary report: N
MALIBU
MDR report key: 1010185
·
Received March 10, 2008
Report
- Report Number
- 9611530-2008-00007
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Date of Event
- August 20, 2007
- Report Date
- February 28, 2008
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION HAS BEEN PROVIDED (NO ACTUAL INVESTIGATION REPORT), DESPITE REPEATED REQUESTS BY THE MANUFACTURER. THEREFORE, THE MANUFACTURER IS CLOSING THE REPORT AS IS, DUE TO LACK OF INFORMATION.
Description of Event or Problem · 1
THE FACILITY REPORTS AFTER BATHING, THE FEMALE RESIDENT WAS TRANSFERRED FROM THE LIFT SEAT ONTO HER WHEELCHAIR WHEN PART OF THE SEAT "BROKE AWAY." HELP WAS AT HAND, AND THE RESIDENT WAS ABLE TO COMPLETE THE TRANSFER WITHOUT INJURY. THE SEAT UNIT HAS BEEN TAKEN OUT OF USE AWAITING INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALIBU | BATHING SYSTEM | ILJ | ARJO HOSPITAL EQUIPMENT AB | AXXXXXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |