FDA Adverse Event
Malfunction
Summary report: N
S3 EX - 3005
MDR report key: 3151382
·
Received June 7, 2013
Report
- Report Number
- 0001831750-2013-05148
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 14, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 FUNCTIONING DUE TO SCREWS WERE BREAKING OFF INTO THE CONNECTOR OF THE WALL INTERFACE CABLE. 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 |
|---|---|---|---|---|---|---|---|
| 253357 | S3 EX - 3005 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |