BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART

    MDR report key: 16397552 · Received February 17, 2023

    Report

    Report Number
    3030677-2023-00732
    Event Type
    Death
    Date Received
    February 17, 2023
    Date of Event
    February 13, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL COMPLAINT INVESTIGATION. THIS BATTERY WAS NOT RETURNED WITH THE DEVICE AND IT CANNOT BE INVESTIGATED FURTHER. THE DEVICE LOGS INDICATE THE BATTERY WAS LOW DUE TO NORMAL DRAIN AND A WARNING BEEP WAS EMITTED TO INDICATE BATTERY ISSUE. THE DEVICE WAS FOUND TO FUNCTION NORMALLY. IT WAS ATTEMPTED TO DOWNLOAD PATIENT DATA, BUT NONE WAS FOUND ON THE DEVICE. NO FAULTS FOUND WERE FOUND WITH THIS DEVICE (NFF-NFF). BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THERE WAS NO DEVICE FAULT FOUND AND THE REPORTED PROBLEM NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE CUSTOMER WOULD BE PROVIDED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THE HS1 DID NOT WORK AS EXPECTED WHEN A PERSON WAS IN NEED OF MEDICAL TREATMENT. NO LIGHTS, NO SOUND. CPR TREATMENT WAS GIVEN UNTIL AN AMBULANCE ARRIVED WITH ANOTHER DEFIBRILLATOR. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135245 HEARTSTART AED MKJ PHILIPS NORTH AMERICA LLC HEARTSTART HS1 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening