FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 1893707
·
Received November 2, 2010
Report
- Report Number
- 1831750-2010-03422
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 5, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: THE UNIT WAS EVALUATED FOR THE USER FACILITY. THE USER FACILITY WAS INFORMED OF THE MALFUNCTION AND IS GOING TO ATTEMPT TO FIX THE ISSUE THEMSELVES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS NOT WORKING PROPERLY. NO ADVERSE CONSEQUENCES HAVE BEEN 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 CORP., MEDICAL DIV | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |