BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED PRO

    MDR report key: 13621217 · Received February 28, 2022

    Report

    Report Number
    1220908-2022-00716
    Event Type
    Death
    Date Received
    February 28, 2022
    Date of Event
    February 4, 2022
    Report Date
    February 7, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    P160022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. HOWEVER, THE CUSTOMER'S BATTERY WAS FOUND TO BE DEPLETED. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE INFORMATION FROM THE CUSTOMER, THE BATTERY INDICATOR ON THE DISPLAY SCREEN SHOWED THREE OUT OF FOUR BARS REMAINING. HOWEVER, THE USER INDICATED THAT THE SHOCK BUTTON MAY HAVE BEEN SLIGHTLY LIT. WHICH INDICATES THAT THE BATTERY'S VOLTAGE DROPPED VERY LOW. BY DESIGN, WHEN THE VOLTAGE DROPS VERY LOW, THE AED SHOCK BUTTON ILLUMINATES. THE DEVICE AND DISPOSABLE BATTERY WERE RECEIVED AT ZOLL JAPAN, AT WHICH TIME THE DEVICE DID NOT PASS THE POWER ON SELF TESTING AND DISPLAY THE RED X INDICATOR. THE AED WAS ABLE TO BE SUCCESSFULLY TURNED ON USING A TEST BATTERY. THE BATTERY WAS INSTALLED ON NOVEMBER 15, 2021 AND USED FOR APPROXIMATELY 2.5 MONTHS. REVIEW OF THE DEVICE LOGS SHOWED THAT THE DEVICE HAD BEEN USED FREQUENTLY FOR BOTH SHOCK PERFORMANCES AND ECG MONITORING, INCLUDING EIGHT CLINICAL LOGS RECORDED THAT TOTALED APPROXIATELY TWO HOURS OF POWER ON TIME. FURTHER EVALUATION OF THE BATTERY BY THE SUPPLIER FOUND ALL CELLS HAD BEEN DRAWN DOWN EVENLY, INDICATING THAT THE CELLS WERE ACTING AS EXPECTED. GIVEN THE LOW CAPACITY OF THE BATTERY, IT IS LIKELY THAT THE FREQUENT USAGE OF THE DEVICE DEPLETED THE BATTERY IN A RELATIVELY SHORT TIME FRAME. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) FEMALE PATIENT, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800390 AED PRO DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION AED PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Death