BEUDAMED
    FDA Adverse Event Summary report: N

    INFINITY DOCKING STATION

    MDR report key: 788459 · Received November 17, 2006

    Report

    Report Number
    1220063-2006-00025
    Date Received
    November 17, 2006
    Date of Event
    June 13, 2006
    Report Date
    November 15, 2006
    Manufacturer
    DRAGER MEDICAL SYSTEMS
    Product Code
    MPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DRAEGER MEDICAL SYSTEMS, INC. RECEIVED THE IDS (INFINITY DOCKING STATION) CORRECTLY ASSEMBLED. A REPRESENTATIVE FROM THE MECHANICAL ENGINEERING GROUP EVALUATED THE ASSOCIATED IDS UNIT BY PERFORMING A SIMULATED FUNCTIONAL TEST BY INSTALLING A PT MONITOR ON THE ASSOCIATED IDS UNIT AND APPLYING FORCE IN A WAY TO POSSIBLY SEPARATE THE TOP COVER FROM THE IDS BASE COMPONENT. THE UNIT WAS ALSO DISASSEMBLED FOR FURTHER ANALYSIS. AN INSPECTION OF THE INTEGRITY OF THE PEM FASTENERS WAS PERFORMED. THIS INVOLVED THE REMOVAL OF THE IDS TOP COVER ASSEMBLY TO EXPOSE THE FASTENERS. EACH FASTENER WAS INSPECTED FOR PROPER INSERTION INTO THE MOLDED PLASTIC AND APPEARED TO BE FINE. THEN A TURNING FORCE WAS APPLIED TO EACH FASTENER TO DETERMINE IF THE PEM NUT COMPONENT WAS SECURELY IN PLACE AND WOULD NOT MOVE (SPIN OR PULL OUT). ALL PEM NUT FASTENERS STAYED IN PLACE, NONE MOVED OR PULLED OUT OF THE MOLDED PLASTIC BOSS. AFTER WE HAD PERFORMED THE ABOVE STATED TESTING, WE RECEIVED INFO FROM OUR LOCAL FIELD OFFICE THAT THE PEM FASTENERS HAD BEEN GLUED INTO THE MOLDED PLASTIC BOSSES AFTER THE REPORTED EVENT HAD OCCURRED. DUE TO THE APPLIED GLUE ON THE PEM FASTENERS, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE REPORTED SEPARATION.

    Description of Event or Problem · 1

    IT WAS COMMUNICATED TO US THAT WHILE THE CUSTOMER WAS USING OUR DELTA PT MONITOR THAT WAS CONNECTED TO OUR IDS (INFINITY DOCKING STATION) THE ANESTHESIOLOGIST SLIPPED AND HIT THE LOWER CORNER OF THE MONITOR WITH HIS ARM. THE MONITOR LIFTED OFF WITH THE UPPER PART OF THE DOCKING STATION AND RESULTED IN THE SEPARATION OF THE TOP COVER SECTION. (WHERE THE PT MONITOR IS MOUNTED) FROM THE BOTTOM SECTION OF THE IDS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DOCKING STATION POWER SUPPLY AND NETWORK COMMUNICATION DEVICE MPE DRAGER MEDICAL SYSTEMS 7265338 546576065

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO