FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZX
MDR report key: 1112086
·
Received August 6, 2008
Report
- Report Number
- 9680128-2008-00065
- Event Type
- Malfunction
- Date Received
- August 6, 2008
- Date of Event
- July 7, 2008
- Report Date
- July 7, 2008
- Manufacturer
- STRYKER MEDICAL QUEBEC
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY CUSTOMER THAT THE BED INDICATED THE FOLLOWING ERROR "HEAD ANGLE OVER EXTENDED AND HEAD, HIGH/LOW AND FOOT MOTORS OVERHEATED". REPORTEDLY, THE CPR FUNCTION COULD NOT BE ACTIVATED AGAIN. NO PATIENT OR USER INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZX | HOSPITAL BED, A-C POWERED, ADJUSTABLE | FNL | STRYKER MEDICAL QUEBEC | 2140 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |