BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE 64

    MDR report key: 2992730 · Received March 1, 2013

    Report

    Report Number
    1525965-2013-00018
    Event Type
    Other
    Date Received
    March 1, 2013
    Date of Event
    February 5, 2009
    Report Date
    February 9, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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) 2007. THE ROOT CAUSE WAS THAT THE IV POLE WAS USED INAPPROPRIATELY BY THE USER APPLYING PRESSURE TO POLE WHEN POLE WAS INSERTED INTO THE HOLDER. THE DESIGN AND INSTRUCTIONS WERE REVIEWED AND DETERMINED THE DESIGN IS NOT INTENDED TO USE THE IV POLE AS A HANDLE. IT WAS SUGGESTED TO REPLACE PARTS AND PROVIDE OPERATING INSTRUCTIONS TO THE USER. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM A SITE STATING THE IV POLE FELL FROM THE HOLDER WITH AN INTRAVENOUS DRIP ON THE POLE. THE ROD HIT THE TABLETOP WITH A PATIENT ON THE TABLE. NO FURTHER PATIENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89384 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1