FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BEDOBS 01/13
MDR report key: 3230033
·
Received July 16, 2013
Report
- Report Number
- 0001831750-2013-06390
- Event Type
- Malfunction
- Date Received
- July 16, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 21, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE NURSE CALL SYSTEM WAS NOT FUNCTIONAL DUE TO BENT 37 PIN CONNECTOR. 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 |
|---|---|---|---|---|---|---|---|
| 328714 | SECURE 3 MED/SURG BEDOBS 01/13 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |