FDA Adverse Event
Death
Summary report: N
POWERED PATIENT ROTATION BED
MDR report key: 1336833
·
Received March 6, 2009
Report
- Report Number
- 1525712-2009-00042
- Event Type
- Death
- Date Received
- March 6, 2009
- Date of Event
- February 2, 2009
- Report Date
- March 5, 2009
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- IKZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER RECEIVED INFORMATION OF A RESIDENT OF A FACILITY WAS FOUND TRAPPED IN ZONE-1 OF A BEDRAIL. BED WAS REPORTEDLY SET UP WITH ONE SET OF HALF RAILS ON THIS BED. MANUFACTURES CURRENT USER GUIDE RECOMMENDS THE USE OF TWO SETS OF HALF RAILS. DEALER ALSO ADVISED THE BED WAS ORIGINALLY SET UP ON THE FIRST FLOOR OF THIS FACILITY AND WAS MOVED TO THE 3RD FLOOR BY AN UNKNOWN SOURCE. MDR FILED BASE DON ALLEGED DEATH.
Description of Event or Problem · 1
THE RESIDENT WAS ALLEGED FOUND DECEASED, TRAPPED IN ZONE 1 OF THE BEDRAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED PATIENT ROTATION BED | 890.5225 | IKZ | INVACARE FLORIDA OPERATIONS | 5410 IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death |