FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 2883850
·
Received November 15, 2012
Report
- Report Number
- 1831750-2012-11904
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 18, 2012
- Report Date
- October 18, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: FOOT SECTION WAS MISSING A PIN AND RUE RING COTTER.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT SECTION WOULD NOT LOCK ON THE BED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD304 MATERNITY BED | LABOR AND DELIVERY BED | HDD | STRYKER MEDICAL | 4701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |