BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3060108 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00951
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    AGILENTTECHNOLOGIES, INC
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WILL NOT WORK ON BATTERY POWER. THERE WAS NO REPORT OF PT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WILL NOT WORK ON BATTERY POWER. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114968 HEART START XL MKJ AGILENTTECHNOLOGIES, INC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1