BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 1483559 · Received July 21, 2009

    Report

    Report Number
    1821850-2009-00003
    Event Type
    Malfunction
    Date Received
    July 21, 2009
    Date of Event
    June 22, 2009
    Report Date
    July 21, 2009
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    PMA / PMN Number
    K972525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO MII AND EXTENSIVELY EVALUATED AND TESTED. THE COMPLAINT COULD NOT BE CONFIRMED. THE UNIT OPERATED FINE ALTHOUGH SLIGHTLY OUT OF SPECIFICATION. EVALUATION SUMMARY: THUMPER (B) (4) WAS RETURNED TO MICHIGAN INSTRUMENTS, INC. FOR EVALUATION. THE COMPLAINT WAS THAT THE UNIT WOULD NOT PERFORM COMPRESSIONS WHEN THE CHEST DEPTH NEEDLE VALVE (CDNV) WAS ADVANCED. INITIALLY, THE UNIT WAS POWERED UP AND FOUND TO BE RUNNING CORRECTLY. IT WAS PERFORMING CHEST COMPRESSIONS AND VENTILATIONS PROPERLY. LONGER TERM TESTING OVER SEVERAL DAYS WAS DONE AND THE REPORTED PROBLEM WAS NOT ABLE TO BE DUPLICATED. ADDITIONAL TESTING FOUND THAT ALTHOUGH THE UNIT DID PERFORM PROPER CPR AS DESIGNED THERE WERE SEVERAL PARAMETERS THAT WERE SLIGHTLY OUT OF SPECIFICATION. THE CDNV ADJUSTMENT WAS MORE SENSITIVE THAN EXPECTED WHICH IS AN INDICATION OF WEAR (NORMAL) IN THE TURBIN VALVE. THE COMPRESSION RATE IS A LITTLE SLOW AT 94.2 COMPRESSIONS PER MINUTE AND THE VENTILATION VOLUMES ARE HIGH. THE DEVICE HAS BEEN REPAIRED AND CALIBRATED.

    Description of Event or Problem · 1

    A PATIENT IN A NURSING FACILITY WAS HAVING TROUBLE BREATHING, HE WENT IN TO RESPIRATORY, THEN CARDIAC ARREST APPROXIMATELY 30 MINUTES PRIOR TO THE ARRIVAL OF PARAMEDIC RESCUE. THE PATIENT WAS PULSELESS AND APNEIC, FACILITY PERSONNEL WERE PERFORMING MANUAL CPR. PARAMEDICS TOOK OVER CPR AND ATTEMPTED TO SWITCH TO MECHANICAL CPR USING THE THUMPER. AFTER SET UP FOR THE PATIENT, THE UNIT WAS TUNED ON BUT THE OPERATOR WAS NOT ABLE TO INITIATE COMPRESSIONS. THE UNIT WAS REMOVED AND MANUAL CPR CONTINUED. THE PATIENT DID NOT SURVIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR