FDA Adverse Event
Malfunction
Summary report: N
MA204
MDR report key: 2961521
·
Received January 17, 2013
Report
- Report Number
- 1831750-2013-90494
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 21, 2012
- Report Date
- December 21, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE NURSE CALL SYSTEM WAS NOT WORKING DUE TO INTERFACE CABLE WAS BROKE AND PULLED FROM THE BED. CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THER WAS ANY PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26125 | MA204 | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL25E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |