BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1193487 · Received October 8, 2008

    Report

    Report Number
    1218950-2008-00540
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED THE DEFIB TEST PORTION OF THE OPCHECK. THE UNIT WAS RETURNED TO PHILLIPS FOR EVALUATION, AND THE REPORTED FAILURE WAS VERIFIED. REPLACEMENT OF THE THERAPY PCA RESOLVED THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED THE DEFIB TEST PORTION OF THE OPCHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MKJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1