BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M SERIES

    MDR report key: 2022506 · Received February 15, 2011

    Report

    Report Number
    1220908-2011-00350
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K990762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION WAS OBSERVED DURING INCOMING TESTING; HOWEVER, AFTER DISASSEMBLING THE DEVICE TO DETERMINE ROOT CAUSE, THE MALFUNCTION WAS NO LONGER SEEN. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. 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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE ADJUSTED THE PACER RATE WHEN THE PACER OUTPUT WAS ADJUSTED. THE DEVICE ALSO ADJUSTED THE PACER OUTPUT WHEN THE PACER RATE WAS ADJUSTED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA