BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 8794616 · Received July 16, 2019

    Report

    Report Number
    1220908-2019-01953
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Report Date
    June 25, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017521
    PMA / PMN Number
    K060559/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY ZOLL MEDICAL CORPORATION. THE REPORTED FAULT OF DISPLAY BLANKS OUT WAS NOT DUPLICATED OR CONFIRMED. THE DEVICE WAS SUBJECTED TO EXTENSIVE TROUBLESHOOTING WHICH INCLUDED FULL FUNCTIONALITY TESTING WITHOUT DUPLICATING THE REPORTED MALFUNCTION. THE REPORTED MALFUNCTION OF ECG DISABLED WAS NOT DUPLICATED UNDER TESTING. HOWEVER REVIEW OF DEVICE'S HISTORY LOGS DOES SHOW OCCURRENCES OF REPORTED ERROR MESSAGES. THE ANALOG BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE AND THE DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589262 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1