FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3173530
·
Received June 17, 2013
Report
- Report Number
- 0001831750-2013-05492
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THAT THE POWER CORD WAS FRAYED WITH EXPOSED ELECTRIC WIRES.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD WAS FRAYED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD WAS FRAYED WITH EXPOSED ELECTRIC WIRES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272926 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |