FDA Adverse Event
Malfunction
Summary report: N
STRYKER BED MODEL 1115 PRIME SERIES BIG WHEEL
MDR report key: 6375785
·
Received March 1, 2017
Report
- Report Number
- MW5068221
- Event Type
- Malfunction
- Date Received
- March 1, 2017
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
STAFF REPORTS WHILE RAISING THE HEAD OF THE BED FOR A PROCEDURE, THE HOB LOWERED ON IT'S OWN. THE HOB WOULD NOT STAY UP. PT WAS LEFT IN FLAT (SUPINE) POSITION BECAUSE BED WOULD NOT STAY ELEVATED. STRYKER REP TO COME TO FACILITY AND EVALUATE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150764 | STRYKER BED MODEL 1115 PRIME SERIES BIG WHEEL | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL | 1115 PRIME SERIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |