FDA Adverse Event
Malfunction
Summary report: N
ADEL LABOR AND DELIVERY BED
MDR report key: 1933269
·
Received December 2, 2010
Report
- Report Number
- 1831750-2010-04324
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 5, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIV.
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT WON'T RAISE UP AND DRIFTED DOWN DURING USE. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADEL LABOR AND DELIVERY BED | LABOR AND DELIVERY BED | HDD | STRYKER CORP. MEDICAL DIV. | 4700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |