BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3802379 · Received February 21, 2014

    Report

    Report Number
    1525965-2014-00029
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 24, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DETERMINED THE CAUSE WAS FROM THE RELAY CONTACTS, WHICH HE CLEANED AND BURNISHED. INTERNAL CROSS REFERENCE: (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN POSITIONING A PT FOR A CLINICAL X-RAY PROCEDURE, INTERMITTENTLY THE TABLETOP WOULD CONTINUE TO DRIVE IN THE LONGITUDINAL DIRECTION WHEN THE ACTUATOR SWITCH WAS RELEASED. PER THE FIELD SERVICE ENGINEER (FSE) THERE WAS NO HARM TO THE PT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110026 NA NA JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 70667

    Patients

    Seq Age Sex Outcome Treatment
    1