BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11953596 · Received June 7, 2021

    Report

    Report Number
    3030677-2021-12049
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 14, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS, THAT THE DEVICE DISPLAYED AN ERROR OPERATIONAL CHECK FAILING. THE CUSTOMER REQUESTED, THAT A PHILIPS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. THE REPORTED ISSUE WAS CONFIRMED, THAT IT WAS A USER ERROR. THE FSE GUIDED AND RE-TRAINED THE USER THROUGH THE CORRECT PROCEDURE. NO REPLACEMENT PARTS REQUIRED. THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED TESTING. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER ACTIONS WERE TAKEN AND NONE ARE WARRANTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE DISPLAYED AN ERROR. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841424 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown