BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PLUS

    MDR report key: 1033421 · Received April 21, 2008

    Report

    Report Number
    1220908-2008-00789
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT REC'D THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PT, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED PLUS DEFIBRILLATOR MKJ ZOLL MEDICAL CORP AED PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK