FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 3820059
·
Received May 20, 2014
Report
- Report Number
- 0001831750-2014-02994
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- HDD
- PMA / PMN Number
- K5950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT SECTION WAS NOT LOCKING IN PLACE DUE TO FOOT SECTION WAS MISSING LEFT SIDE LOCKING PIN. 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 |
|---|---|---|---|---|---|---|---|
| 300090 | LD304 MATERNITY BED | TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES) | HDD | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |