BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER BLUE VELCRO TOURNIQUET

    MDR report key: 2903856 · Received December 31, 2012

    Report

    Report Number
    MW5028472
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 31, 2012
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TOURNIQUET APPLIED ON LIMB AND HOOKED TO RED INSUFFLATION TUBING FOR SURGICAL PROCEDURE. TOURNIQUET INFLATED AND MACHINED ALARMED. TOURNIQUET FAILED AND CIRCULATING NURSE CHANGED INSUFFLATION TUBING TO BLUE TUBING. TOURNIQUET CONTINUED TO FAIL WHEN INFLATED. REPLACED TOURNIQUET MACHINE AND TOURNIQUET CONTINUED TO FAIL WHEN INFLATED. DATES OF USE: (B)(6) 2012. DIAGNOSIS OR REASON FOR USE: ORTHOPEDIC SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER BLUE VELCRO TOURNIQUET PNEUMATIC TOURNIQUET 30" KCY STRYKER INSTRUMENTS 5921-030-701

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR