BEUDAMED
    FDA Adverse Event Death Summary report: N

    X SERIES

    MDR report key: 7651209 · Received June 29, 2018

    Report

    Report Number
    1220908-2018-01769
    Event Type
    Death
    Date Received
    June 29, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 8, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    PMA / PMN Number
    K112432/P160
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION REPRESENTATIVE EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. DURING REVIEW OF THE ACTIVITY LOGS CONCLUDED THAT THE DEVICE PROPERLY IDENTIFIED AND RECOGNIZED THE PADS, BUT DID NOT DISPLAY THE SIGNAL ON THE SCREEN DUE TO PADS VIEW NOT BEING SELECTED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, WHO HAD A STROKE, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN PERFORMED CPR TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491549 X SERIES DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION X SERIES NA
    491550 MKJ

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death