BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 11391818 · Received March 1, 2021

    Report

    Report Number
    11391818
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 14, 2021
    Report Date
    February 23, 2021
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTED BY TRAUMA SURGEON. CRITICAL TRAUMA PATIENT IN THE OPERATING ROOM, REQUIRING INTERNAL DEFIBRILLATION TO RESTORE CARDIAC ACTIVITY. DEFIBRILLATOR FAILED TO DELIVER DEFIBRILLATION. SENT TO BIOMED AND BIOMED RAN A DIAGNOSTIC AND THE ERROR CODES WERE DISCOVERED AT THIS TIME. THE CODES WERE RELATED TO A CHARGING CIRCUIT ERROR. THE EQUIPMENT WAS REMOVED FORM SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288837 HEART START XL AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS ELECTRONICS NORTH AMERICA CORPORATION M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA