BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 6631737 · Received June 9, 2017

    Report

    Report Number
    1220908-2017-01299
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Report Date
    May 19, 2017
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DPS
    UDI-DI
    00847946004170
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE CLINICAL DATA AND ELECTRODE PADS WERE NOT RETURNED TO ZOLL MEDICAL CORPORATION AS PART OF THIS INVESTIGATION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    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 ALLEGED THAT DURING SUBSEQUENT TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412765 M SERIES DEFIBRILLATOR/PACEMAKER DPS ZOLL MEDICAL CORPORATION MSERIES BI-PHASIC NA 00847946004170

    Patients

    Seq Age Sex Outcome Treatment
    1