BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2042908 · Received March 30, 2011

    Report

    Report Number
    1218950-2011-00836
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AGILENTTECHNOLOGIES, INC
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE SCREEN ON THE DEVICE WAS BLANK. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZED TO THE CONTROL PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN ON THE DEVICE WAS BLANK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1