FDA Adverse Event
Malfunction
Summary report: N
MA204
MDR report key: 2971977
·
Received January 21, 2013
Report
- Report Number
- 1831750-2013-90511
- Event Type
- Malfunction
- Date Received
- January 21, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 20, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 HEAD OF THE BED WAS WORKING INTERMITTENTLY. CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29134 | MA204 | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL25E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |