FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 3181899
·
Received June 21, 2013
Report
- Report Number
- 0001831750-2013-05612
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 29, 2013
- Report Date
- May 29, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SIDERAILS WERE DAMAGED AND WOULD NOT LOCK UPRIGHT. 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 BY REPAIR WORK ORDER THAT THE SIDERAILS WOULD NOT LOCK UPRIGHT. 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 |
|---|---|---|---|---|---|---|---|
| 283425 | SECURE II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |