BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART START XL

    MDR report key: 11610463 · Received April 2, 2021

    Report

    Report Number
    3030677-2021-10651
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    February 14, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE FAILED TO DELIVER A SHOCK TO A PATIENT IN THE OPERATING ROOM, WHO REQUIRED INTERNAL DEFIBRILLATION TO RESTORE CARDIAC ACTIVITY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED TO DELIVER A SHOCK TO A PATIENT IN THE OPERATING ROOM, WHO REQUIRED INTERNAL DEFIBRILLATION TO RESTORE CARDIAC ACTIVITY. 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. MULTIPLE REQUESTS WERE MADE FOR ADDITIONAL PATIENT/PROCEDURE INFORMATION, HOWEVER, NO ADDITIONAL DETAILS WERE RECEIVED. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. MULTIPLE REQUESTS WERE MADE FOR EVALUATION INFORMATION, HOWEVER, NO ADDITIONAL DETAILS WERE RECEIVED. MULTIPLE REQUESTS WERE MADE FOR RESOLUTION INFORMATION, HOWEVER, NO ADDITIONAL DETAILS WERE RECEIVED. THE DEVICE REMAINS WITH THE CUSTOMER. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED TO DELIVER A SHOCK TO A PATIENT IN THE OPERATING ROOM, WHO REQUIRED INTERNAL DEFIBRILLATION TO RESTORE CARDIAC ACTIVITY. 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
    505369 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention