FDA Adverse Event
Injury
Summary report: N
AMBULIFT CLASSIC
MDR report key: 2699503
·
Received March 10, 2010
Report
- Report Number
- 3004468271-2010-00006
- Event Type
- Injury
- Date Received
- March 10, 2010
- Date of Event
- February 8, 2010
- Report Date
- February 8, 2010
- Manufacturer
- MEDIBO MEDICAL PRODUCTS NV
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
POWERED AMBULIFT WITH SUB-CHASSIS HAD BEEN ATTACHED TO CHAIR AND LOWERED TO FLOOR BUT CHAIR DID NOT DISENGAGE AS SAFETY CATCH HAD NOT BEEN RELEASED. CHAIR WAS THEN RAISED SLIGHTLY, CATCH RELEASED AND CHAIR DETACHED FROM JIB. AT THIS STATE THE PT FELL FORWARD OUT OF THE CHAIR AND HIT HER HEAD ON THE FLOOR. THE SAFETY STRAP WAS NOT FITTED AND ONE ARM ON THE COMMODE CHAIR HAD BEEN RAISED TO ALLOW TRANSFER OF PT. IT WAS REPORTED THAT THE COMMODE SEAT WAS THEN FOUND DETACHED FROM THE COMMODE CHAIR FRAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBULIFT CLASSIC | HYGIENE AND POOL LIFTER | FSA | MEDIBO MEDICAL PRODUCTS NV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |