BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1953949 · Received December 15, 2010

    Report

    Report Number
    1218950-2010-02573
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DISPLAY ON THE DEVICE WAS NOT FUNCTIONING AT ALL. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED AT THE PHILIPS REPAIR BENCH AND THE SYMPTOM WAS VERIFIED. REPLACING THE CONTROL PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY ON THE DEVICE WAS NOT FUNCTIONING AT ALL. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ AGILENT TECHNOLOGIES, INC. M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1