BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 19378588 · Received May 22, 2024

    Report

    Report Number
    3030677-2024-01780
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 28, 2024
    Report Date
    June 23, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    K021453
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) WITH AN INVESTIGATION DOCUMENTED BY PHILIPS COMPLAINT HANDLING. ANALYSIS WAS PERFORMED BY CUSTOMER ONLY. BASED ON THE RESULTS OF THE ANALYSIS PROVIDED BY CUSTOMER, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO THE DEFECTIVE ECG LEADS TRUNK CABLE. THE ISSUE WAS RESOLVED BY REPLACING THE ECG LEADS TRUNK CABLE AND THE PRODUCT IS BACK IN SERVICE. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. REPORTING ADDRESS POSTAL = 060 061103 CN.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART XL INDICATING THAT THE THE DEVICE DID NOT SHOW ECG WAVEFORM NORMALLY. WHEN THE CUSTOMER NEEDS TO USE A DEFIBRILLATOR TO RESET THE ATRIAL FIBRILLATION HEART RATE OF A PATIENT DUE TO A RESURGENCE OF ATRIAL FIBRILLATION, THE DEFIBRILLATOR DOES NOT DISPLAY THE ECG PROPERLY, RESULTING IN THE INABILITY TO USE THE SYNCHRONIZED RESET FUNCTION. CUSTOMER USED ANOTHER DEFIBRILLATOR IMMEDIATELY AND THERE WAS NO PATIENT HARM OR INJURY REPORTED TO PHILIPS. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT, WHEN THE PATIENT SUDDENLY USED THE DEFIBRILLATOR TO REPEAT THE HEART RATE OF ATRIAL FIBRILLATION AGAIN DUE TO ATRIAL FIBRILLATION, THE SYNCHRONOUS CARDIOVERSION FUNCTION COULD NOT BE USED BECAUSE THE DEFIBRILLATOR COULD NOT DISPLAY THE ELECTROCARDIOGRAM NORMALLY. THE EMERGENCY DEPARTMENT DEFIBRILLATOR WAS IMMEDIATELY DEPLOYED TO PERFORM SYNCHRONOUS ELECTRICAL CARDIOVERSION. NORMAL HEART RATE WAS SUCCESSFULLY RESTORED WITHOUT ADVERSE EFFECTS ON THE PATIENT. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789200 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening