BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLA 500/700

    MDR report key: 7766273 · Received August 9, 2018

    Report

    Report Number
    9611500-2018-00252
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 19, 2018
    Report Date
    November 7, 2018
    Manufacturer
    DRAEGERWERK AG & CO. KGAA
    Product Code
    FTD
    PMA / PMN Number
    K010724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED ONDAL SPRING ARM WAS EXAMINED BY DRÄGER SERVICE ON SITE. IN THE SPECIAL DEVICE SOLUTION, THE SPRING ARM IS USED AS A CEILING SUPPORT SYSTEM FOR 2 MONITORS BY ANKLIN INSTEAD OF A SOLA 500/700; THIS CONSTRUCTION IS ONLY IMPLEMENTED ONCE IN THE CLINIC. THE REPORTED PROBLEM COULD BE CONFIRMED. DURING THE ANALYSIS IT WAS DETERMINED THAT THE CIRCLIP (C-RING) HAD COME OUT OF THE GROOVE OF THE PEG RECEIVER OF THE CANTILEVER, CAUSING THE ARM TO SLIP AND ONLY BE HELD BY THE INTERNAL CABLES. THE AFFECTED CIRCLIP WAS OPTICALLY EXAMINED BY THE MANUFACTURER WITH A DIGITAL CAMERA MICROSCOPE. THIS VISUAL INSPECTION SHOWED A CONSIDERABLE PLASTIC DEFORMATION IN THE RADIAL AND AXIAL DIRECTION. NO DESIGN OR MANUFACTURING ERROR WAS FOUND. THIS EXCESSIVE DEFORMATION OVER THE ELASTIC OR REVERSIBLE AREA INDICATES THAT THE RING WAS EXCESSIVELY STRETCHED DURING THE ASSEMBLY AND THUS PLASTICALLY IRREVERSIBLY DEFORMED. IT IS THEREFORE LIKELY THAT THE RING WAS NOT PLACED CORRECTLY IN THE PROVIDED PIN GROOVE DUE TO THE DEFORMATION WHICH LED TO A DISLODGEMENT OF THE RING FROM THE GROOVE. THE INSTALLATION INSTRUCTIONS INCLUDE WARNINGS TO PREVENT DAMAGE TO THE SAFETY RING DURING ASSEMBLY. THE SPRING ARM INCLUDING THE RETAINING RING AND THE CABLE WAS REPLACED ON OCTOBER 10TH AND HAS BEEN IN OPERATION AGAIN SINCE THEN.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL-REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED: AT A ONDALSPACE SPRINGARM (SER. 3014H000255029; REV. 1844070) THE C-RING LOOSENED FROM THE GROOVE AND THE SPRING ARM LOWERED FOR ABOUT 1.5 CM. SOME CABLES WERE DAMAGED DUE TO THIS. THE C-RING HAS BEEN REPLACED ABOUT THREE YEARS AGO. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607380 SOLA 500/700 LIGHTS FTD DRAEGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1