BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1843649 · Received September 20, 2010

    Report

    Report Number
    3015876-2010-01044
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 26, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE; HOWEVER, THE REPORTED FAILURE WAS NOT VERIFIED NOR DUPLICATED. PROPER OPERATION WAS CONFIRMED DURING FUNCTIONAL AND PERFORMANCE TESTING. THE POWER SUPPLY PCB AND THE MAIN KEYPAD ASSEMBLIES WERE REPLACED AS A PRECAUTIONARY MEASURE AND THE DEVICE WAS RETURNED TO THE CUSTOMER. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLIES; HOWEVER, THE REPORTED FAILURE WAS NOT DUPLICATED. THE CAUSE OF THE REPORTED ISSUE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE PARAMEDICS WERE USING THE DEVICE TO TREAT A PT DURING A CARDIAC ARREST CALL. THE PT HAD LAST BEEN SEEN 2 1/2 HOURS PRIOR TO THE CALL. THE PT'S DOWNTIME WAS NOT KNOWN. IT WAS REPORTED THAT WHEN THE DEVICE OPERATOR ATTEMPTED TO CHARGE THE DEFIBRILLATOR, THE DEVICE REPORTEDLY LOST POWER. THE UNIT WAS THEN TURNED BACK ON AND AGAIN REPORTEDLY LOST POWER WHEN THE CHARGE BUTTON WAS PRESSED. AN AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) WAS SUBSEQUENTLY MADE AVAILABLE BY FIRE DEPARTMENT PERSONNEL ON THE SCENE. NO SHOCKS WERE ADVISED BY THE AED. THE PT WAS NOT RESUSCITATED. A CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THE DEVICE USE DID NOT IMPACT THE PT'S OUTCOME. DEFIBRILLATION WAS NOT INDICATED BASED ON ECG. THE PT EVENT CONTINUOUS ECG RECORD SHOWS AN INITIAL ECG WITH ARTIFACT. ALSO, THE POWER OFF/OR EPISODE DURATION WAS 41 SECONDS AND, BASED ON THE IMPEDANCE WAVEFORM AND ECG, IT IS EVIDENT THAT CPR WAS BEING GIVEN TO THE PT. FOLLOWING A PERIOD OF CPR, THE PT'S ECG SHOWS AN ORGANIZED RHYTHM. THE AED APPLIED TO THE PT PROVIDED A NO SHOCK ADVISED DETERMINATION. THE PT IS REPORTED TO HAVE A MEDICAL HISTORY OF HYPERTENSION AND RENAL FAILURE AND THE DOWNTIME WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR