BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 12071934 · Received June 25, 2021

    Report

    Report Number
    3030677-2021-12502
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    June 23, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    K021453
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THE DEVICE WOULD NOT POWER ON AND WOULD NOT STAY ON DURING ATTEMPT SHOCK PATIENT DURING CODE. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. THE FSE FOUND THAT THE DEVICE WAS NOT CHARGING AT ALL. THE POWER CORD WAS NOT CONNECTED TO THE DEFIBRILLATOR. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. THE FSE CONNECTED THE POWER CORD AND ALLOWED THE DEFIBRILLATOR TO CHARGE FOR A FEW HOURS. AFTER BEING CHARGED, THE FSE RAN PERFORMANCE ASSURANCE TESTING WHICH PASSED. THE FSE ADVISED THE NURSE TO CHECK THAT THE POWER CORD IS FULLY CONNECTED WHEN THEY CHECK THE CRASH CART. NO PARTS WERE REPLACED. THE DEVICE WAS PLACED BACK INTO USE WITH THE CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THE DEVICE WOULD NOT POWER ON AND WOULD NOT STAY ON DURING ATTEMPT SHOCK PATIENT DURING CODE. ADDITIONAL DETAILS HAVE BEEN REQUESTED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963981 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R