BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2896177 · Received November 20, 2012

    Report

    Report Number
    1218950-2012-03883
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AGILENTTECHNOLOGIES, INC
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE UNIT DOES NOT CHARGE THE BATTERY. NO PT INVOLVEMENT WAS REPORTED. A PHILIPS BENCH TECH EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DIAGNOSED AS AN AC POWER SUPPLY FAILURE. THE AC POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT DOES NOT CHARGE THE BATTERY. NO PT INVOLVEMENT WAS REPORTED.

    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