BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2102345 · Received May 18, 2011

    Report

    Report Number
    1218950-2011-01420
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 THAT THE UNIT FAILED TO POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED LOCALLY BY A PHILIPS REP AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE BATTERY RESOLVED THE FAILURE. THE UNIT PASSED ALL POST-SERVICE TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1