FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2021383
·
Received February 16, 2011
Report
- Report Number
- 1831750-2011-01402
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: SIDERAIL, MOTION INTERRUPT PAN. CONCLUSION: THE USER HAD REMOVED THE SIDERAIL FROM THE BED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE MOTION INTERRUPT PAN WAS MISSING. IT WAS FURTHER REPORTED THAT THE CUSTOMER HAD REMOVED THE HEAD RIGHT SIDERAIL. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |