FDA Adverse Event
Malfunction
Summary report: N
ADEL OBS 6/04
MDR report key: 3040964
·
Received April 8, 2013
Report
- Report Number
- 0001831750-2013-03004
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- December 31, 2012
- Report Date
- March 14, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEADEND LIFT WAS STUCK IN AN ELEVATED POSITION DUE TO A BROKEN TREND BRACKET. 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 |
|---|---|---|---|---|---|---|---|
| 144045 | ADEL OBS 6/04 | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | HDD | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |