BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11632126 · Received April 7, 2021

    Report

    Report Number
    3030677-2021-10784
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 17, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WON'T TURN ON. THE CUSTOMER REQUESTED THAT A PHILIPS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. THE REPORTED ISSUE WAS CONFIRMED AND IT WAS DETERMINED THAT THE INTERNAL CONNECTIONS NEEDED TO BE RESEATED. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THE INTERNAL CONNECTIONS NEEDED TO BE RESEATED. AFTER THE FSE RESEATED THE INTERNAL CONNECTIONS THE REPORTED ISSUE WAS RESOLVED. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WON'T TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WON'T TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529379 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1