BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX AIRWORTHY

    MDR report key: 3031276 · Received March 5, 2013

    Report

    Report Number
    1218950-2013-00764
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER LED FLICKERS WHEN THE AC CORD IS MOVED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER LED FLICKERS WHEN THE AC CORD IS MOVED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94761 HEARTSTART MRX AIRWORTHY DRO LDD MKJ MKJ PHILIPS MEDICAL SYSTEMS 861464

    Patients

    Seq Age Sex Outcome Treatment
    1