FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 2110403
·
Received April 25, 2011
Report
- Report Number
- 1831750-2011-03935
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 11, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT - LIFT LIMITS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED WILL NOT LOWER AND THE AUXILIARY POWER CORD WAS DAMAGED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
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 | UNK |