FDA Adverse Event
Other
Summary report: N
LIFTER
MDR report key: 303870
·
Received November 4, 2000
Report
- Report Number
- 2182305-2000-00019
- Event Type
- Other
- Date Received
- November 4, 2000
- Date of Event
- August 31, 2000
- Report Date
- September 25, 2000
- Manufacturer
- SUNRISE MEDICAL
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT FELL DURING TRANSFER USING A PT LIFTER. PER FACILITY, THE HYD BENT, PT DID NOT GO THE HOSP 'EXAM AND X-RAYS TAKEN THERE' RESULTS WERE OK. REPAIR TECH WAS DISPATCHED TO FACILITY FOR EVAL AND REPAIR. THE REPAIR TECH CALLED IN DURING THE REPAIR TO INFORM CO THAT HE HAS TAKEN PICTURES OF THE LIFT, AND THE FACILITY HAD CUT THE ACUTATOR CORD AND WIRED DIRECTLY INTO THE PT BOARD, BYPASSING THE ACTUATOR SOCKET. [END USER HAD MODIFIED THE LIFT TO AN UNSAFE STATE; CO REMOVED LIFT AND ARE IN THE PROCESS OF REPAIRING BACK TO ITS ORIGINAL STATE] !
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFTER | PT LIFTER | FNJ | SUNRISE MEDICAL | PB400 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |