FDA Adverse Event
Malfunction
Summary report: N
BASIC CONFIGURATION LD304 MODEL 4701
MDR report key: 2914916
·
Received December 7, 2012
Report
- Report Number
- 1831750-2012-12669
- Event Type
- Malfunction
- Date Received
- December 7, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- HDD
- PMA / PMN Number
- K950889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
MFR'S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE (B)(4), THAT THE HEAD END WAS RAISING BUT WILL NOT GO DOWN. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC CONFIGURATION LD304 MODEL 4701 | LABOR AND DELIVERY BED | HDD | STRYKER MEDICAL | 4701BASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |