BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1833471 · Received September 8, 2010

    Report

    Report Number
    1218950-2010-01509
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Report Date
    July 14, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A PHILIPS REP EVALUATED THE UNIT AND THE REPORTED SYMPTOM WAS DUPLICATED. THE CONTROL AND KEYSCAN PCA WERE REPLACED TO RESOLVE THE REPORTED ISSUE. BASED ON THE AVAILABLE INFO, WE COULD NOT DETERMINE THE CAUSE SINCE MULTIPLE PCAS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SCREEN WAS BLANK.

    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