FDA Adverse Event
Malfunction
Summary report: N
S3 EX - 3005
MDR report key: 2891769
·
Received November 29, 2012
Report
- Report Number
- 1831750-2012-12197
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 1, 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
RESULT: INCORRECT DIP SWITCH SETTINGS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE NURSE CALL BUTTON WOULD SIGNAL THE BED EXIT DUE TO THE DIP SWITCH SETTINGS BEING SET INCORRECTLY. THE CUSTOMER COULD NOT DETERMINE WHETHER THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S3 EX - 3005 | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |