FDA Adverse Event
Malfunction
Summary report: N
LD304 MATERNITY BED
MDR report key: 1902442
·
Received November 12, 2010
Report
- Report Number
- 1831750-2010-03690
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 14, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: SIDE RAIL COVERS, SIDE RAIL INNER AND OUTER PANELS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BIRTHING BED SIDE RAIL COVERS AND PANEL PLASTIC IS BROKEN. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LD304 MATERNITY BED | LABOR AND DELIVERY BED | HDD | STRYKER CORP., MEDICAL DIV. | 4701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |