FDA Adverse Event
Malfunction
Summary report: N
ATS 1200 TOURNIQUET SYSTEM
MDR report key: 3832012
·
Received March 7, 2014
Report
- Report Number
- 1526350-2014-00177
- Event Type
- Malfunction
- Date Received
- March 7, 2014
- Date of Event
- February 1, 2014
- Report Date
- February 7, 2014
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- KCY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATS 1200 TOURNIQUET SYSTEM PROBLEM WAS WITH THE DEFLATION AND MAINTAINING DESIRED PRESSURE WHEN INFLATED. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138783 | ATS 1200 TOURNIQUET SYSTEM | ATS 1200 TOURNIQUET SYSTEM | KCY | ZIMMER SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |