BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2083094 · Received April 12, 2011

    Report

    Report Number
    1218950-2011-00989
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE REPEATEDLY FAILED, THE USER INITIATED SHIFT/EXTENDED SELF TEST WITH AN ERROR CODE OF 90007 (PACER FAILURE). THERE WAS NO INTERRUPTION OF THE TEST PROCESS, AND THERE WAS NO PATIENT INVOLVEMENT. 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 REPEATEDLY FAILED, THE USER INITIATED SHIFT/EXTENDED SELF TEST WITH AN ERROR CODE OF 90007 (PACER FAILURE). THERE WAS NO INTERRUPTION OF THE TEST PROCESS, AND THERE WAS NO PATIENT 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