BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11717176 · Received April 23, 2021

    Report

    Report Number
    3030677-2021-11180
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 4, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 CHARGE FAILED ON THE DEVICE. THE PATIENT HAD CARDIAC ARREST PRIOR TO DEVICE ISSUES. THE CUSTOMER DID NOT RESPOND TO MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A POSSIBLE DELAY IN LIFE SAVING THERAPY AND WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ISSUE. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED, THE CAUSE CANNOT BE DETERMINED.

    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 THAT THE CHARGE FAILED ON THE DEVICE. THE PATIENT HAD CARDIAC ARREST PRIOR TO DEVICE ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, CAUSING A POSSIBLE 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
    612531 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R