BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3934559 · Received July 15, 2014

    Report

    Report Number
    3015876-2014-00806
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL ALSO PERFORMED A CLINICAL EVALUATION OF THE REPORTED EVENT. THE ECG PRINTED STRIPS SHOWED THAT THE PATIENT WAS IN VENTRICULAR TACHYCARDIA WITH SYNC MARKERS LOCATED AT THE NEGATIVE PEAK OF THE WAVEFORM IN THE PRE-SHOCK ECG. WHEN THE FIRST SHOCK OF 150 JOULES WAS DELIVERED, THE PATIENT¿S RHYTHM CONVERTED TO VENTRICULAR FIBRILLATION. THE SECOND SHOCK (ASYNCHRONOUS AT 200 JOULES) WAS NOT SUCCESSFUL IN CONVERTING THE RHYTHM. THE THIRD SHOCK (ASYNCHRONOUS AT 200 JOULES) CONVERTED THE RHYTHM BACK TO A SINUS RHYTHM. PHYSIO-CONTROL CONCLUDED THAT THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION OR USE ERROR. CONVERSION FROM VENTRICULAR TACHYCARDIA TO VENTRICULAR FIBRILLATION IS A KNOWN COMPLICATION OF SYNCHRONIZED CARDIOVERSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY USED THEIR LIFEPAK® 15 MONITOR/DEFIBRILLATOR TO PERFORM SYNCHRONIZED CARDIOVERSION ON A PATIENT. THE SYNC (SYNCHRONIZE) FUNCTION WAS TURNED ON (EVIDENCED BY THE TRIANGLE SYNC MARKERS ON THE PRINT-OUT OF THE PATIENT'S ECG). THE CUSTOMER REPORTED THE DEVICE WAS NOT SYNCHRONIZING CORRECTLY. A 150 JOULE SHOCK WAS DELIVERED AND INDUCED THE PATIENT TO GO INTO VENTRICULAR FIBRILLATION. A SECOND SHOCK (ASYNCHRONOUS AT 200J) WAS NOT SUCCESSFUL IN CONVERTING THE RHYTHM. THE THIRD SHOCK (ASYNCHRONOUS AT 200J) SUCCESSFULLY CONVERTED THE RHYTHM BACK TO SINUS RHYTHM PER THE HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412372 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R