FDA Adverse Event
Malfunction
Summary report: N
MA204
MDR report key: 2933589
·
Received December 21, 2012
Report
- Report Number
- 1831750-2012-13311
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 4, 2012
- Report Date
- December 4, 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
LOAD CELL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED HAD THE FOLLOWING ISSUES: SCALE WAS OFF BY 12 LBS., POWER CORD WAS DAMAGED, HEAD CASTER BRAKES WERE NOT HOLDING. 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 | MA204 | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL25E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |