BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2083166 · Received April 13, 2011

    Report

    Report Number
    1218950-2011-01025
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 16, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A PROBLEM WITH THE DISPLAY ON THE DEVICE. THE DEVICE WAS EVALUATED BY A LOCAL THIRD PARTY SERVICE PROVIDER. THE SYMPTOM WAS CLARIFIED AS THE BOTTOM PART OF THE DISPLAY NOT FUNCTIONING. REPLACING THE DISPLAY ASSEMBLY RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE DISPLAY ON THE DEVICE. THE DEVICE WAS EVALUATED BY A LOCAL THIRD PARTY SERVICE PROVIDER. THE SYMPTOM WAS CLARIFIED AS THE BOTTOM PART OF THE DISPLAY NOT FUNCTIONING. REPLACING THE DISPLAY ASSEMBLY RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1