BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINIX VPE

    MDR report key: 2994338 · Received March 1, 2013

    Report

    Report Number
    1525965-2013-00019
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 16, 2007
    Report Date
    February 26, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K940721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) OF 2007. THE FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE TABLE WAS NOT LOCKING PROPERLY DUE TO THE BRAKE PADS HAD COME LOOSE FROM THE TWO VERTICALLY ACTUATED BRAKE PISTONS. THE FSE SERVICED THE SYSTEMS AND TESTED THE BRAKES FOR NORMAL OPERATION BEFORE GIVING THE SYSTEM BACK TO THE OPERATOR. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT WHERE THE OPERATOR SUSTAINED A BACK INJURY WHILE HAVING TO HOLD A PATIENT DUE TO THE TABLE NOT LOCKING PROPERLY. INFORMATION WAS RECEIVED THAT THE OPERATOR WAS OFF OF WORK FOR A FEW DAYS BUT NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89913 CLINIX VPE JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1