BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R SERIES DEFIBRILLATOR

    MDR report key: 1981491 · Received January 11, 2011

    Report

    Report Number
    1220908-2010-03831
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K060559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PACE A (B)(6) MALE PT WITH A BRADY RHYTHM, THE DEVICE FAILED TO CAPTURE THE PT'S HEART RHYTHM WHEN THEY PLACED STAT PADS ON THE PT. THE CLINICIAN INDICATED THAT THE PT WAS MEDICATED WHICH WOULD CAUSE THE DEVICE NOT TO CAPTURE THE PT'S HEART RHYTHM. THE CLINICIAN GAVE THE PT CALCIUM TO HELP STABILIZE THE PT'S HEART RHYTHM. THE DEVICE DID CAPTURE THE PT'S HEART RHYTHM AFTERWARDS, HOWEVER, IT WAS OBSERVED THAT THE DEVICE DISPLAYED A "RED X". COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR