FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2160608
·
Received June 30, 2011
Report
- Report Number
- 1831750-2011-06647
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: BROKEN SIGNAL COIL LITTER CONNECTOR WITH EXPOSED WIRES. FAULTY FOOTBOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE LITTER SIGNAL COIL CORD CONNECTOR WAS BROKEN WITH EXPOSED WIRES, AND THE FOOTBOARD WAS NOT FUNCTIONING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE 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 |