FDA Adverse Event
Malfunction
Summary report: N
S3 MED/SURG BED
MDR report key: 5719713
·
Received June 13, 2016
Report
- Report Number
- 5719713
- Event Type
- Malfunction
- Date Received
- June 13, 2016
- Date of Event
- June 6, 2016
- Report Date
- June 7, 2016
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOB (HEAD OF BED) WOULD NOT ELEVATE OR DESCEND WITH ANY OF THE CONTROL BUTTONS. WHEN ANY BUTTON WAS PRESSED TO ELEVATE THE HOB, THE BED WOULD MAKE A HUMMING SOUND. THIS PATIENT WAS IN THE POST OPERATIVE PERIOD AND HAVING PAIN. THE BED WAS REPAIRED BY CLINICAL ENGINEERING AND RETURNED TO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376110 | S3 MED/SURG BED | BED, PATIENT, AC POWERED | FNL | STRYKER MEDICAL | 3005S3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | NO THIS EVENT OCCURRED IMMEDIATELY POST OP |