FDA Adverse Event
Malfunction
Summary report: N
ADEL OBS 6/04
MDR report key: 1853063
·
Received September 21, 2010
Report
- Report Number
- 1831750-2010-02481
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: BED WAS OUT OF CALIBRATION.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT, THE BED WOULD NOT GO TO LOW HEIGHT. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADEL OBS 6/04 | LABOR AND DELIVERY BED | HDD | STRYKER CORP., MEDICAL DIV. | 4700 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |