BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART

    MDR report key: 17852775 · Received October 2, 2023

    Report

    Report Number
    3030677-2023-03906
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    August 23, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN DEEMED A DUPLICATE OF PR 3896041. DEVICE INVESTIGATION WILL TAKE PLACE ON (B)(4).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THE AEDS LOCATED AT SEVERAL ELEMENTARY SCHOOLS WERE SETTING OFF ALARMS AT SIMILAR TIMES. PRESSED THE I-BUTTON ON THE AED THAT ALARMED, ""REMOVE & REINSTALL BATTERY"" MESSAGE OCCURRED. THE ALARM RETURNS WHEN THE BATTERY IS REINSTALLED, BUT THE SAME ALARM OCCURS AGAIN A MONTH LATER. THE CUSTOMER IS VERY CONFUSED BECAUSE THE SAME SYMPTOMS OCCURRED IN SEVERAL AEDS THAT WERE DELIVERED AT THE SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099713 HEARTSTART AED MKJ PHILIPS NORTH AMERICA LLC HEARTSTART HS1 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown