BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2508753 · Received March 26, 2012

    Report

    Report Number
    1218950-2012-01028
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Report Date
    March 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DISPLAY HAS HORIZONTAL LINES. THE DEVICE WAS EVALUATED AT PHILIPS AND THE REPORTED SYMPTOM WAS VERIFIED. THE DATA ON THE DISPLAY WAS UNCLEAR ON THE SCREEN. THE LCD DISPLAY ASSEMBLY WAS REPLACED TO RESOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DISPLAY HAS HORIZONTAL LINES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1