BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 8151609 · Received December 11, 2018

    Report

    Report Number
    1220908-2018-03606
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Report Date
    November 28, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017200
    PMA / PMN Number
    K060559/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO CODE: MKJ. THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY ECG SHIELD ON THE ANALOG BOARD. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "ECG DISABLED" AND "DEFIB PAD SHORT" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990333 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA 00847946017200

    Patients

    Seq Age Sex Outcome Treatment
    1