FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 2933588
·
Received December 21, 2012
Report
- Report Number
- 1831750-2012-13312
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 28, 2012
- Report Date
- November 28, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: PENDANT BUTTON STUCK.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED MOTIONS WERE NOT FUNCTIONAL. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH EU | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | 2131 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |