FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BED
MDR report key: 1915215
·
Received November 16, 2010
Report
- Report Number
- 1831750-2010-03862
- Event Type
- Malfunction
- Date Received
- November 16, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: BED EXTENDER. CONCLUSION: USER FACILITY USED THE INCORRECT VINTAGE OF BED EXTENDER ON THE DEVICE CAUSING AN ALERT DUE TO THE INCOMPATIBLE BED EXTENDER BEING USED. THE PRODUCT PERFORMED TO SPECIFICATION. FACILITY WAS ADVISED ON USING THE PROPER BED EXTENDER.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED ALARM IS NOT WORKING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE 3 MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIV. | 3002S3EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |