BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 16362099 · Received February 13, 2023

    Report

    Report Number
    3030677-2023-00663
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 23, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE (861288 HEARTSTART MRX MONITOR/DEFIB) INDICATING THAT THE SYSTEM FAILED THE SELF-TEST. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. AVAILABLE DETAILS INDICATE THAT THE DEVICE FAILED THE SELF-TEST. THE CUSTOMER WANTED TO CONTACT THE DISTRIBUTOR, BURSCH, TO REPAIR THE DEVICE. THE DEVICE WAS NOT AVAILABLE FOR ADDITIONAL INVESTIGATION. NO FURTHER ACTION IS REQUIRED AT THIS TIME. H3 OTHER TEXT : REMOTE SUPPORT PROVIDED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART MRX SYSTEM DID NOT PASS THE SELF-TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673624 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown