BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 5022152 · Received August 17, 2015

    Report

    Report Number
    1220908-2015-02146
    Event Type
    Death
    Date Received
    August 17, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 7, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K112432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF ACTIVITY LOGS SHOWED OCCURRENCES OF PADS ON/PADS OFF MESSAGES. EVALUATION OF THE IMPEDANCE PLOT INDICATED THAT THE READINGS FOR THE FIRST SEVEN MINUTES WERE ERRATIC AND MOSTLY OUT OF A VALID IMPEDANCE RANGE. THIS DOES NOT INDICATE A DEVICE MALFUNCTION, BUT MAY INDICATE POOR COUPLING BETWEEN THE ELECTRODE PADS AND THE PATIENT'S SKIN. ADDITIONALLY, UPON VISUAL INSPECTION OF THE PADS, THERE WERE SMALL AMOUNTS OF HAIR ON THE PADS AND A SIGNIFICANT AMOUNT OF HAIR IN THE RETURNED PACKAGING. WE CANNOT FIRMLY CONCLUDE POOR PATIENT PREPARATION. THIS REPORT HAS BEEN ATTRIBUTED TO POOR COUPLING OF THE ELECTRODE PADS TO THE PATIENT'S SKIN. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543398 X SERIES DEFIBRILLATOR/PACEMAKER MKJ ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death