BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCLAW - VENTILATOR MOUNTING CLAMP

    MDR report key: 2506928 · Received March 14, 2012

    Report

    Report Number
    2242630-2011-00115
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    December 5, 2011
    Report Date
    March 10, 2011
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    FOX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAMP WAS RETURNED TO IMPACT, REPAIRED (JAW WAS REPLACED AND THE KNOB THREADS WERE REWORKED TO PREVENT THE JAW FROM BEING FORCED OFF THE CLAMP IN ORDER TO PREVENT REOCCURRENCE) AND RETURNED TO THE USER ALONG WITH NOTICE REGARDING ITS PROTOTYPE STATUS. CLAMP WAS CLEARLY LABELLED: "PROTOTYPE: NOT FOR USE WITH HUMAN PTS."

    Description of Event or Problem · 1

    CUSTOM/PROTOTYPE VERSION OF IMPACT INSTRUMENTATION'S CCLAW VENTRICULAR MOUNTING CLAMP PROVIDED FOR EVAL OF FIT ONLY TO AIR AMBULANCE COMPANY ((B)(4)). CLAMP WAS NOT TO BE USED WHILE PTS WERE TREATED HOWEVER, IT WAS TO BE USED IN SUCH APPLICATION. CLAMP HAD BROKEN PRIOR TO THIS INCIDENT (THE MOVEABLE JAW PORTION OF THE CLAMP WAS MISSING WHEN IN USE) AND WAS INCORRECTLY REPAIRED BY THE END USER (USED W/O THE JAW PORTION BY ATTEMPTING TO KEEP THE CLAMP FROM SLIDING DOWN THE POLE BY USING SURGICAL GAUZE). VENTRICULAR WAS REPORTED TO HAVE SLID DOWN THE MOUNTING POLE AND TO HAVE CAUSED A MINOR/TEMPORARY INJURY TO THE PT BEING TRANSPORTED. IT WAS REPORTED THAT MINOR FIRST-AID ONLY WAS REQUIRED TO TREAT THE PT. NO FURTHER DETAILS REGARDING THE INJURY WERE MADE AVAILABLE FROM THE END-USER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCLAW - VENTILATOR MOUNTING CLAMP INFUSION STAND FOX IMPACT INSTRUMENTATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other