BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PRO

    MDR report key: 5042960 · Received August 31, 2015

    Report

    Report Number
    1220908-2015-02158
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 10, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. THE REPORTED CONDITION OF THE DEVICE'S DISPLAY BLANKING OUT WAS NOT OBSERVED, HOWEVER, THE EVENT BATTERY FAILED TESTING. ADDITIONALLY, THE DEVICE'S COULOMB COUNTER WAS NEVER RESET BY THE CUSTOMER WHICH COULD HAVE LEAD TO THE REPORTED EVENT. REVIEW OF THE ECG DATA FOUND THAT THE PRESENTED HEART RHYTHM FAILED TO MEET THE DEVICE'S REQUIREMENTS FOR DEFIBRILLATION AND THE DEVICE APPROPRIATELY RETURNED A "NO SHOCK ADVISED" PROMPT. BASED ON THE EXTENT OF THE BASELINE DISTURBANCE (NOISE) DURING THE ANALYSIS IN QUESTION, THE DEVICE RESPONDED APPROPRIATELY. THE BASELINE DISTURBANCE IS CONSISTENT WITH CPR BEING PERFORMED DURING ANALYSIS. THE DEVICE WORKED AS DESIGNED AND CONFIGURED AND WITHIN THE LIMITATIONS OF THE TECHNOLOGY AVAILABLE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT 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 GAVE A "NO SHOCK ADVISED" PROMPT FOR A RHYTHM CLINICIANS BELIEVED WAS SHOCKABLE. THE DEVICE'S DISPLAY ALSO INTERMITTENTLY BLANKED OUT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576239 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1