BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 6056670 · Received October 26, 2016

    Report

    Report Number
    1218950-2016-06729
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Report Date
    October 8, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE AED HAS INTERFERENCE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708153 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1