BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2082031 · Received April 26, 2011

    Report

    Report Number
    1218950-2011-01135
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 28, 2011
    Manufacturer
    AGILENTTECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED AND ERROR CODE 00020 (DEFIB SUPPLY VOTAGE ERROR) WAS ENTERED IN THE SYSTEM LOG. THERE WAS NO REPORT OF PT INVOLVEMENT OR ADVERSE PT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED AND ERROR CODE 00020 (DEFIB SUPPLY VOTAGE ERROR) WAS ENTERED IN THE SYSTEM LOG. THERE WAS NO REPORT OF PT INVOLVEMENT OR ADVERSE PT IMPACT.

    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