FDA Adverse Event
Malfunction
Summary report: N
S3 SIGNATURE
MDR report key: 2861147
·
Received November 2, 2012
Report
- Report Number
- 1831750-2012-11480
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 8, 2012
- Report Date
- October 8, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THERE WAS NO POWER TO THE AUXILIARY OUTLET. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S3 SIGNATURE | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002S3SIGNATURE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |