BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PRO

    MDR report key: 3130995 · Received May 17, 2013

    Report

    Report Number
    1220908-2013-01333
    Event Type
    Death
    Date Received
    May 17, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, THE DEVICE WAS UNABLE TO DETECT THE ATTACHED ECG LEADS. COMPLAINANT INDICATED THAT THE CLINICIAN SWITCHED TO PADS DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT WAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220082 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death