FDA Adverse Event
Malfunction
Summary report: N
SECURE ACUTE CARE BED 3/01
MDR report key: 3033719
·
Received April 3, 2013
Report
- Report Number
- 0001831750-2013-02884
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 8, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS. CUSTOMER REPLACED THE POWER CORD THEMSELVES TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD WAS DAMAGED. 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 BED HAD NO POWER DUE TO THE POWER CORD BEING DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135656 | SECURE ACUTE CARE BED 3/01 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |