BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2231245 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-02108
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 28, 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). THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED AN ERROR CODE 20004. ERROR CODE 20004 IS ACCOMPANIED BY THE CYCLE POWER MESSAGE/INSTRUCTION, OPERATION IS INTERRUPTED AND POWERING OFF AND ON IS REQUIRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ADVERSE PATIENT IMPACT.

    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