BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 13565457 · Received February 20, 2022

    Report

    Report Number
    3030677-2022-01040
    Event Type
    Malfunction
    Date Received
    February 20, 2022
    Date of Event
    January 24, 2022
    Report Date
    February 18, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEFIBRILLATOR HAD A "BAD BATTERY". THE EVENT OCCURRED DURING CLINICAL USE BUT THERE WAS REPORTEDLY NO PATIENT HARM. THE CUSTOMER EVALUATED THE DEVICE AND RECEIVED REMOTE SUPPORT FROM THE CUSTOMER CARE SOLUTION CENTER, DURING WHICH A QUOTE WAS PROVIDED FOR DIAGNOSTIC SERVICE. ALTHOUGH NO EVALUATION WAS PERFORMED, THIS WILL BE DOCUMENTED AS A MALFUNCTION THAT OCCURRED AT THE TIME OF THE REPORTED EVENT, THE CAUSE OF WHICH WAS NOT DETERMINED. 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 THAT THE DEFIBRILLATOR HAD A "BAD BATTERY". THE EVENT OCCURRED DURING CLINICAL USE BUT THERE WAS REPORTEDLY NO PATIENT HARM. THE CUSTOMER EVALUATED THE DEVICE AND RECEIVED REMOTE SUPPORT FROM THE CUSTOMER CARE SOLUTION CENTER, DURING WHICH A QUOTE WAS PROVIDED FOR DIAGNOSTIC SERVICE. ALTHOUGH NO EVALUATION WAS PERFORMED, THIS WILL BE DOCUMENTED AS A MALFUNCTION THAT OCCURRED AT THE TIME OF THE REPORTED EVENT, THE CAUSE OF WHICH WAS NOT DETERMINED. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358750 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown