FDA Adverse Event
Other
Summary report: N
IN TOUCH ZU
MDR report key: 1901204
·
Received November 10, 2010
Report
- Report Number
- 9680128-2010-00289
- Event Type
- Other
- Date Received
- November 10, 2010
- Date of Event
- October 13, 2010
- Report Date
- October 19, 2010
- Manufacturer
- STRYKER MEDICAL QUEBEC LP
- Product Code
- FNL
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY, A PT FELL OUT OF THE BED IN THE ICU DEPARTMENT. IT WAS REPORTED, THE BED EXIT ALARM WAS SET, HOWEVER, IT IS ALLEGED THE ALARM DID NOT GO OFF WHEN THE PT EXITED THE BED AND THE PT FELL. NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZU | HOSPITAL BED, A-C POWERED, ADJUSTABLE | FNL | STRYKER MEDICAL QUEBEC LP | 2141000000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |