FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2873700
·
Received November 14, 2012
Report
- Report Number
- 1831750-2012-11861
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 26, 2012
- Report Date
- October 26, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: SCALE CALIBRATED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS INACCURATE. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
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 |