FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZX
MDR report key: 3181897
·
Received June 21, 2013
Report
- Report Number
- 0001831750-2013-05613
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 28, 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 SIDERAIL WOULD NOT LOCK DUE TO BROKEN CASTING. 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 |
|---|---|---|---|---|---|---|---|
| 282070 | IN TOUCH ZX | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |