FDA Adverse Event
Malfunction
Summary report: N
ADEL OBS 6/04
MDR report key: 3232439
·
Received July 18, 2013
Report
- Report Number
- 0001831750-2013-06437
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 24, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- 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 VIA REPAIR WORK ORDER THAT THE BED LIFT WAS DRIFTING DUE TO MALFUNCTION DRIVE TUBE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334498 | ADEL OBS 6/04 | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | HDD | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |