BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PRO

    MDR report key: 12570485 · Received October 4, 2021

    Report

    Report Number
    1220908-2021-03212
    Event Type
    Death
    Date Received
    October 4, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 13, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    UDI-DI
    00847946016142
    PMA / PMN Number
    K110526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE CLINICAL EVENT DATA FROM THE EVENT WAS RETURNED AND EVALUATED. REVIEW OF THE DATA INDICATED THE DEVICE ECG ALGORITHM IDENTIFIED 2 OF THE 3 ANALYZED ECG SEGMENTS AS SHOCKABLE. THE ECG WAVEFORM CHANGED BETWEEN THE 1ST AND 2 SECOND SEGMENTS. HOWEVER THE PADS USED DO NOT ALLOW CPR DATA RECORDING AND WERE NOT RETURNED FOR EVALUATION. IT WAS DETERMINED THAT THE DEVICE WORKED AS DESIGNED AND CONFIGURED, WITHIN THE LIMITATIONS OF THE TECHNOLOGY AVAILABLE. THE AED PRO DEVICE INVOLVED IN THIS EVENT IS NOT AUTOMATIC. THE DEVICE ECG ALGORITHM PROMPTS WITH A RECOMMENDATION BASED ON THE EVALUATED ECG WAVEFORM. THE DEVICE DOES NOT PROVIDE THERAPY WITHOUT ACTIVATION OF THE SHOCK BUTTON BY THE OPERATOR. THEREFORE, THIS CLAIM HAS BEEN CLOSED AS DEVICE MEETS SPECIFICATION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER THEY BELIEVE IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466100 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA 00847946016142

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Death