BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X SERIES

    MDR report key: 8214346 · Received January 3, 2019

    Report

    Report Number
    1220908-2018-03810
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Report Date
    December 13, 2018
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    DRT
    UDI-DI
    00847946004354
    PMA / PMN Number
    K112432/P160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. DEVICE EVALUATION: THE REPORTED MALFUNCTION OF THE DEVICE WAS UNABLE TO RECOGNIZE A BATTERY WAS INSTALLED AND INAPPROPRIATELY INDICATED AC POWER WAS DUPLICATED AND THE BATTERY CONNECTION ASSEMBLY WAS REPLACED TO RESOLVE THE MALFUNCTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. THE REPORTED MALFUNCTION OF UNKNOWN ERROR MESSAGE WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED BENCH HANDLING AND FULL FUNCTIONAL STRESS TESTING WITHOUT ANY ERROR MESSAGES. REVIEW OF THE ERROR LOGS DID NOT FIND EVIDENCE TO SUPPORT THE REPORTED EVENT. REVIEW OF THE DEVICE LOG DID SEE OCCURRENCES OF NIBP CUFF BLOCK MESSAGES. REPORTS OF THIS NATURE ARE TYPICALLY NOT CONSIDERED TO HAVE ANY CLINICAL IMPACT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL AND DISPLAYED UNKNOWN ERROR MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE THE DEVICE WAS UNABLE TO RECOGNIZE A BATTERY WAS INSTALLED AND INAPPROPRIATELY INDICATED AC POWER. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5968 X SERIES DEFIBRILLATOR/PACEMAKER DRT ZOLL MEDICAL CORPORATION X SERIES NA 00847946004354

    Patients

    Seq Age Sex Outcome Treatment
    1