FDA Adverse Event
Malfunction
Summary report: N
S3 EX - 3005
MDR report key: 2870551
·
Received November 14, 2012
Report
- Report Number
- 1831750-2012-11934
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 22, 2012
- Report Date
- October 22, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INLET CABLE. AUXILIARY POWER CORD. THIS ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE INLET CABLE AND AUXILIARY POWER CORD AND VERIFYING THE BED WAS OPERATING PER SPECIFICATION AND AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS NO POWER TO THE BED DUE TO A SHORT BETWEEN THE AUXILIARY POWER CORD AND THE BED FRAME. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S3 EX - 3005 | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3005S3EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |