BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2456305 · Received February 8, 2012

    Report

    Report Number
    1218950-2012-00434
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Report Date
    January 13, 2012
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE BATTERY CHARGE LED LIGHT WAS NOT WORKING. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE SYMPTOM WAS VERIFIED. THE BATTERY PCA AND AC POWER SUPPLY WERE REPLACED TO RESOLVE THE ISSUE. WE ARE UNABLE TO DETERMINE A CAUSE BECAUSE MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BATTERY CHARGE LED LIGHT WAS NOT WORKING. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1