BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 5449827 · Received February 20, 2016

    Report

    Report Number
    1220908-2016-00355
    Event Type
    Malfunction
    Date Received
    February 20, 2016
    Report Date
    February 3, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRO
    PMA / PMN Number
    K112432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: DRT, MKJ. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL (B)(4) EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS OBSERVED BUT NOT DUPLICATED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE'S MONITOR BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. 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 FAILED SELF-TEST FOR PACER, DEFIB, AND ECG. 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
    106067 X SERIES DEFIBRILLATOR/PACEMAKER DRO ZOLL MEDICAL CORPORATION X SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1