BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PRO

    MDR report key: 5522580 · Received March 24, 2016

    Report

    Report Number
    1220908-2016-00824
    Event Type
    Death
    Date Received
    March 24, 2016
    Date of Event
    February 16, 2015
    Report Date
    March 18, 2016
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS FOLLOW UP MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY TRANSISTOR ON THE FLEX CIRCUIT ASSEMBLY. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND THE DEVICE INAPPROPRIATELY DISPLAYED AN "ATTACH PADS" MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS AND PROMPTED "CHECK PADS". COMPLAINANT INDICATED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178915 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death