FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 3073489
·
Received April 23, 2013
Report
- Report Number
- 0001831750-2013-03698
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 3, 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 SIDERAIL WAS NOT LOCKING IN UP POSITION DUE TO MALFUNCTION SIDERAIL. 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 |
|---|---|---|---|---|---|---|---|
| 175066 | LD304 MATERNITY BED | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | HDD | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |