BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 7400371 · Received April 5, 2018

    Report

    Report Number
    1220908-2018-00921
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Report Date
    March 16, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017439
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A DAMAGED ETCH ON A TRANSFORMER ON THE ANALOG BOARD. CAUSE OF THE DAMAGE COULD NOT BE CONFIRMED AS PART OF THE INVESTIGATION. 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 & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN SWITCHED OVER TO LEADS TO OBTAIN THE ECG AND CONTINUED TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242316 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA 00847946017439

    Patients

    Seq Age Sex Outcome Treatment
    1