FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3063574
·
Received April 17, 2013
Report
- Report Number
- 0001831750-2013-03401
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 25, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED AS THIS COMPLAINT WAS PREVIOUSLY REPORTED IN MEDWATCH #0001831750-2013-03277.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT HOLDING DUE TO MALFUNCTION CASTER. 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 BRAKES WERE NOT HOLDING DUE TO MALFUNCTION CASTER. 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 |
|---|---|---|---|---|---|---|---|
| 164035 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |