BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 9132402 · Received September 28, 2019

    Report

    Report Number
    1220908-2019-02838
    Event Type
    Malfunction
    Date Received
    September 28, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946017163
    PMA / PMN Number
    K060559/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE MALFUNCTION WAS OBSERVED DURING REVIEW OF THE DEVICE'S HISTORY LOG. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED FULL FUNCTIONALITY TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE'S ANALOG BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE PASSED THE FINAL TEST PROCEDURE, WAS RECERTIFIED, AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ADDITONAL 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 "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
    926390 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION R SERIES NA 00847946017163

    Patients

    Seq Age Sex Outcome Treatment
    1