FDA Adverse Event
Death
Summary report: N
MARISA
MDR report key: 1580455
·
Received January 7, 2010
Report
- Report Number
- 9617021-2010-00004
- Event Type
- Death
- Date Received
- January 7, 2010
- Date of Event
- December 20, 2009
- Report Date
- December 22, 2009
- Manufacturer
- ARJO MED AB LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE, BROKEN PART, AND SLING HAVE ALL BEEN CONFISCATED AND WERE NOT MADE AVAILABLE FOR EVALUATION. ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
THE FACILITY REPORTS THEY WERE TRANSFERRING THE RESIDENT FROM THE WHEELCHAIR TO THE BED. THE RESIDENT WAS SUSPENDED ABOUT FOUR FEET IN THE AIR WHEN THE NUT CAP FAILED (PART THAT CONNECTS THE SPREADER BAR TO THE JIB). THE ENTIRE PART RELEASED AND THE RESIDENT FELL TO THE FLOOR, SUSTAINING HEAD INJURIES (NOT DEFINED) AND A FRACTURED PELVIS. THE RESIDENT LATER DIED IN THE HOSP. THE POLICE HAVE TAKEN THE LIFT, BROKEN PARTS, AND SLING FOR THEIR OWN INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARISA | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO MED AB LTD. | KGB2100-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |