BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 1485603 · Received August 6, 2009

    Report

    Report Number
    1821850-2009-00004
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    March 14, 2009
    Report Date
    August 6, 2009
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO MICHIGAN INSTRUMENTS, INC. AND EXTENSIVELY EVALUATED AND TESTED. THE SPECIFIC COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE PERFORMED TO ITS SPECIFICATIONS. HOWEVER, THE ON/OFF KNOB WAS DAMAGED WHICH WOULD HAVE THE POTENTIAL TO CAUSE THE SITUATION DESCRIBED. EVALUATION SUMMARY/THUMPER (B) (4): THUMPER (B) (4) WAS RETURNED TO MICHIGAN INSTRUMENTS, INC. FOR EVALUATION. THE COMPLAINT WAS THAT THE UNIT STARTED INCREASING COMPRESSION DEPTH ON ITS OWN. WHEN THE OPERATOR ATTEMPTED TO PAUSE COMPRESSIONS, SHE COULD NOT AND THEN THE UNIT STOPPED AND COULD NOT BE STARTED. INITIALLY, THE UNIT WAS POWERED UP AND FOUND TO BE RUNNING CORRECTLY. IT PERFORMED CHEST COMPRESSIONS AND VENTILATIONS PROPERLY AND TO ITS SPECIFICATIONS. LONGER TERM TESTING OVER SEVERAL HOURS WAS DONE AND THE DEVICE CONSISTENTLY OPERATED WITHIN ITS SPECIFICATIONS. THE REPORTED PROBLEM WAS NOT ABLE TO BE DUPLICATED. HOWEVER, DURING THE EVALUATION, IT WAS FOUND THAT THE ON/OFF SWITCH HAD BEEN DAMAGED FROM DROPPING THE UNIT OR SOME OTHER IMPACT TO THE SWITCH. THIS COULD ALSO BE CONFIRMED BY THE FACT THAT THE SWITCH BRACKET WAS BENT AND THE COVERS WERE DISLODGED. THE DAMAGE TO THE SWITCH CAUSED IT TO RESPOND VERY SLOWLY OR POSSIBLY NOT AT ALL. THIS CONDITION COULD POTENTIALLY RESULT IN THE SITUATION THAT WAS DESCRIBED. THE SWITCH HAS BEEN REPLACED AND THE DEVICE REPAIRED.

    Description of Event or Problem · 1

    RESCUE ARRIVED ON THE SCENE TO FIND A PATIENT PULSELESS AND APNEIC FROM A DRUG OVERDOSE. VENTILATION AND CPR ( COMPRESSIONS). THUMPER WAS APPLIED AFTER THE PATIENT WAS LOADED INTO THE AMBULANCE. INITIALLY, THE THUMPER WAS PERFORMING PROPER COMPRESSIONS. AFTER SEVERAL SECONDS, THERE WAS AN INCREASE IN THE DEPTH/FORCE OF THE COMPRESSIONS. THE OPERATOR ATTEMPTED TO PAUSE THE DEVICE BUT WAS UNABLE TO. THE THUMPER THEN PAUSED ON ITS OWN AND ATTEMPTS TO START IT WERE UNSUCCESSFUL. THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL COMPRESSIONS CONTINUED. UPON ARRIVAL AT THE HOSPITAL, SPONTANEOUS CIRCULATION HAD RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR