BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 16794981 · Received April 24, 2023

    Report

    Report Number
    3030677-2023-01691
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 24, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS FIELD SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE ALS 861288 (HEARTSTART MRX MONITOR/DEFIB) INDICATING THAT THE DEVICE IS BEEPING AND DISPLAYING A RED "X." THE EVENT WAS IN USE AND THERE WAS NO REPORTED PATIENT NOR USER HARM. VISUAL INSPECTION FOUND THE DEVICE IS BEEPING AND IS DISPLAYING A RED "X." THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: OPERATIONAL CHECK, CONTROLS CHECK AND SHOCK TEST. RESULTS OF FUNCTIONAL TESTING INDICATE THE DEVICE IS OPERATIONAL, AS ALL TESTS AND PARAMETERS WERE SUCCESSFULLY COMPLETED. THE ISSUE DID NOT REOCCUR FOLLOWING THE OPERATIONAL CHECK. THE DEVICE WAS FULLY FUNCTIONAL AND RETURNED TO SERVICE. NO REPAIRS WERE NEEDED. NO PARTS WERE REPLACED. DEVICE REMAINS AT THE CUSTOMER SITE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519566 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown