BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 18352505 · Received December 18, 2023

    Report

    Report Number
    3030677-2023-05016
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    January 4, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : THE CUSTOMER PROVIDED THE INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE SITE¿S CLINICAL ENGINEERING MANAGER AND THE PHILIPS SALES REPRESENTATIVE HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE MRX INDICATING THAT DEFIBRILLATOR PADS ARE NOT ADHERING PROPERLY. THIS CASE IS BEING CREATED TO DOCUMENT THE REPORT OF PADS NOT ADHERING PROPERLY DURING A CUSTOMER¿S TEST/ ROOT CAUSE ANALYSIS (RCA) PROCEDURE. THE CUSTOMER PERFORMED AN IN-HOUSE IMPROVISED PAD TESTING PROCEDURE. THE CUSTOMER PROVIDED THE FOLLOWING TESTING INFORMATION. A MANIKIN TEST APPARATUS WAS SET UP TO DELIVER A CHARGE AND SEE WHAT HAPPENS TO THE DEFIBRILLATOR PAD. THE TESTING WAS COMPLETED ON A MANIKIN ENERGY SELECTED AT 150J WHICH DELIVERED 150J VIA PAD, LOT NUMBER 220921-4032. IT WAS NOTED THAT THE PAD ADHESIVE DID NOT ¿FEEL¿ AS STICKY AS IT SHOULD BE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE ISSUE WAS RELATED TO THE PADS. THE REPORTED PROBLEM WAS CONFIRMED ONLY BY THE CUSTOMER. PHILIPS HAS NOT BEEN ABLE TO CONFIRM THE PAD ADHESION ISSUE. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME EVEN THOUGH THE CUSTOMER DID AN IN-HOUSE IMPROVISED PAD TESTING PROCEDURE IT IS NOT POSSIBLE TO CONFIRM OR DETERMINE THE CAUSE OF ANY RELATED PAD ADHESION ISSUES. THE CUSTOMER HAD NO PADS TO GIVE TO PHILIPS FOR THEIR ANALYSIS. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267903 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 220921-4032 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown