BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 6027067 · Received October 13, 2016

    Report

    Report Number
    1218950-2016-06491
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    September 20, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED PART INFORMATION TO RECTIFY THE REPORTED PROBLEM. CUSTOMER TO PURCHASE PARTS AND CONDUCT REPAIRS IN HOUSE. THIS WILL BE CONSIDERED A MALFUNCTION OF THE PROCESSOR AND THERAPY PCA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILS THE OPERATIONAL CHECK. THERE WAS NO REPORTED PATIENT INVOLVEMENT/ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677851 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1