BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 22784327 · Received August 12, 2025

    Report

    Report Number
    3030677-2025-001842
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    August 9, 2025
    Report Date
    November 27, 2025
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000001
    PMA / PMN Number
    K021453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. IT WAS DETERMINED THAT THE DEVICE NUMBER CANNOT BE MODIFIED AND THE CASE WAS CANCELLED. ADDITIONALLY, THERE IS INSUFFICIENT INFORMATION AVAILABLE TO SUPPORT A FINAL FAILURE ANALYSIS. THE DEVICE REMAINS AT THE CUSTOMER SITE, AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THERE WAS NO DEVICE MALFUNCTION. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RETRACTED AS IT IS A DUPLICATE OF THE REPORT SUBMITTED ON MDR #3030677-2025-001845. PLEASE DISREGARD THIS REPORT.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART XL DEFIBRILLATOR MONITOR INDICATING THAT THERE WAS AN ERROR. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401567 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A 00884838000001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown