BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11638159 · Received April 8, 2021

    Report

    Report Number
    3030677-2021-10829
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 19, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT EVALUATION : THE MANUFACTURER'S AUTHORIZED FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND CONFIRMED THE REPORTED PROBLEM. CUSTOMER RESOLUTION AND CONCLUSION : UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE LABEL SET, WHICH WAS REPLACED AND THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE THERAPY LABEL WAS PEELING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE THERAPY LABEL WAS PEELING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533382 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown