BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2140650 · Received June 17, 2011

    Report

    Report Number
    1218950-2011-01729
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT UPON POWER ON THE DEVICE DISPLAYED ERROR CODE 10003 WITH THE MESSAGE/INSTRUCTION TO CYCLE POWER. THERE WAS NO PT INVOLVEMENT. THE LOCAL PHILIPS REPRESENTATIVE CONFIRMED THIS CONDITION AND RESOLVED THE ISSUE BY REFORMATTING THE EXTERNAL DATA (MEMORY) CARD WHICH CLEARS THIS MEMORY CARD CAPACITY RELATED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON POWER ON THE DEVICE DISPLAYED ERROR CODE 10003 WITH THE MESSAGE/INSTRUCTION TO CYCLE POWER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1