FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 2974573
·
Received February 22, 2013
Report
- Report Number
- 0001831750-2013-01454
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 29, 2013
- Report Date
- January 29, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT - USER FACILITY TO REPAIR AND PLACE BACK INTO SERVICE.UNIT WAS EVALUATED BY ENGINEERS AT THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LOSS OF SUPPORT ON THE STIRRUP ASSEMBLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78397 | LD304 MATERNITY BED | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | HDD | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |