BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 13804585 · Received March 18, 2022

    Report

    Report Number
    3030677-2022-01604
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    March 4, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    THE BENCH TECHNICIAN FOUND THE DEVICE NEEDS A POWER CORD. THE PHILIPS REPRESENTATIVE HAS IDENTIFIED THE AC POWER CORD IS A MALFUNCTIONING PART. A QUOTE HAS BEEN SENT TO CUSTOMER TO REPLACE THIS PART. ONCE QUOTE APPROVED THE CORD WILL L BE REPLACED AND THEN THE DEVICE WILL BE VALIDATED BY PERFORMANCE ASSURANCE TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE SUDDENLY SHUTS DOWN. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30539 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown