FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 2864653
·
Received November 9, 2012
Report
- Report Number
- 1831750-2012-11766
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- August 29, 2012
- Report Date
- October 13, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE TECH THAT THE BED COMPONENT WAS DAMAGED. THERE WAS NO PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD304 MATERNITY BED | A/C HOSPITAL BED | HDD | STRYKER MEDICAL | 4701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |