BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11666066 · Received April 14, 2021

    Report

    Report Number
    3030677-2021-10986
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 26, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REQUESTED THAT A PHILIPS FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. UPON EVALUATION OF THE DEVICE, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS TRACED TO A FAULTY MRX KIT DISPLAY 3 & FACE PLATE ASSEMBLY. BASED ON THE CONCLUSION OF THE INVESTIGATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE MRX KIT DISPLAY 3 & FACE PLATE ASSEMBLY. THE MRX KIT DISPLAY 3 & FACE PLATE ASSEMBLY WAS REPLACED AND THE DEVICE PASSED ALL TESTING. THE DEVICE REMAINS AT THE CUSTOMER SITE. THERE IS NO INDICATION OF A SYSTEMIC PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    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 DISPLAY FOR THE UNIT WASN'T FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DISPLAY FOR THE UNIT WASN'T FUNCTIONING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563803 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown