BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 9438980 · Received December 9, 2019

    Report

    Report Number
    1220908-2019-03763
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    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 CUSTOMER'S REPORT OF "POOR PAD CONTACT" MESSAGE WAS OBSERVED DURING REVIEW OF THE DEVICE'S HISTORY LOG. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED BENCH HANDLING AND FULL FUNCTIONALITY TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE ANALOG BOARD WAS REPLACED AS A PRECAUTION. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND. THE CUSTOMER'S REPORT OF UNIT SHUTTING OFF ON ITS OWN WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED BENCH HANDLING, FUNCTIONALITY TESTING, INSPECTION OF THE DISPLAY, POWER TEST, AND POWER CONNECTION WITHOUT DUPLICATING THE MALFUNCTION. REVIEW OF THE DEVICE LOGS DID NOT FIND EVIDENCE TO SUPPORT THE REPORTED EVENT. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER.

    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 BIOMED TESTING, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232517 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION R SERIES NA 00847946017521

    Patients

    Seq Age Sex Outcome Treatment
    1