BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEARTSTART FRX

    MDR report key: 22045165 · Received May 19, 2025

    Report

    Report Number
    3030677-2025-001353
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Report Date
    August 20, 2025
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006560
    PMA / PMN Number
    P180028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED THE UDI TO (B)(4).

    Additional Manufacturer Narrative · 0

    BAD IN MFR REPORT NUMBER 3030677-2025-001353 SHOULD BE 13MAY2025.

    Additional Manufacturer Narrative · 0

    UPDATED METHOD CODE GRID.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE STATUS INDICATOR IS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167262 PHILIPS HEARTSTART FRX AED MKJ PHILIPS NORTH AMERICA LLC HEARTSTART FRX 00884838006560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown