BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2241491 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02330
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 14, 2011
    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 POWER SUPPLY IS NOT CHARGING THE BATTERY OR POWERING UP THE UNIT CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE ISSUE WAS RESOLVED BY REPLACING THE POWER SUPPLY AND POWER PCA. THE UNIT PASSED ALL POST SERVICE TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE POWER SUPPLY IS NOT CHARGING THE BATTERY OR POWERING UP THE UNIT CORRECTLY. THERE WAS NO PATIENT INVOLVEMENT.

    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