BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    34 SINGLE PORT DISPOSABLE TOURNIQUET CUFF

    MDR report key: 1079948 · Received July 16, 2008

    Report

    Report Number
    1035617-2008-00007
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER SALES ASSOCIATES CONTACTED THE HOSPITAL AND INFORMED ZIMMER THAT THE CUFFS WOULD NOT BE RETURNED TO ZIMMER FOR EVAL. IT WAS HOSPITAL POLICY NOT TO RELEASE PRODUCTS INVOLVED IN THE EVENTS. THE CUFF WAS REPROCESSING SINGLE USE DISPOSABLE DEVICES; HOWEVER, HOSPITAL STATED THAT THE CUFFS INVOLVED WERE NEW CUFFS. HOSPITAL TYPICALLY USES 34" CUFFS FOR MOST CASES. CUFFS WERE NOT BEING USED WITH A ZIMMER TOURNIQUET. PICTURES RETURNED APPEAR TO BE IMPROPER CUFF APPLICATION WAS BEING USED.

    Description of Event or Problem · 1

    THE CIRCULATING NURSE REPORTED THAT THE TOURNIQUET CUFF HAD ROLLED UP ON ITSELF. IT WENT UNNOTICED UNTIL THE END OF THE CASE. SHE REPORTED NO INJURY TO THE PT. SOFTROLL WAS USED. TOURNIQUET INFLATED LESS THAN ONE HOUR. TOURNIQUET MACHINE UTILIZED IN THIS CASE WAS AN OLDER MACHINE MADE BY ELECTROMEDICS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 34 SINGLE PORT DISPOSABLE TOURNIQUET CUFF DISPOSABLE CUFF KCY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS 60844698

    Patients

    Seq Age Sex Outcome Treatment
    1