BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1821566 · Received August 27, 2010

    Report

    Report Number
    1218950-2010-01421
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DISPLAY SCREEN WAS BLANK. THE DEVICE WAS EVALUATED BY A PHILIPS REP AND THE REPORTED SYMPTOM WAS VERIFIED. MULTIPLE PARTS WERE REPLACED TO RESOLVE THE ISSUE. WE CANNOT DETERMINE THE CAUSE BECAUSE MORE THAN ONE PART WAS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY 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