BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 21170346 · Received January 16, 2025

    Report

    Report Number
    3030677-2025-000169
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Report Date
    April 15, 2025
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED THE CONCLUSION CODE GRID.

    Additional Manufacturer Narrative · 0

    THE INITIAL "DATE RECEIVED BY MANUFACTURER" ON EMDR 5613414 WITH MFR REPORT NUMBER 3030677-2025-000169 SHOULD BE 13JANUARY2025.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253019 HEARTSTART ONSITE AED MKJ PHILIPS NORTH AMERICA LLC M5066A 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown