BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSUFFLATOR

    MDR report key: 18358 · Received December 12, 1994

    Report

    Report Number
    MW1004400
    Event Type
    Malfunction
    Date Received
    December 12, 1994
    Date of Event
    October 7, 1994
    Report Date
    December 6, 1994
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN OPERATING ROOM NURSE CONNECTED THE INSUFFLATOR TO A NITROGEN TANK THINKING IT WAS THE CARBON DIOXIDE TANK. THREE PTS HAD PROCEDURES IN WHICH THE NITROGEN WAS USED; NONE REQUIRED TREATMENT. THE RPTR STATED THAT THE HOSE FROM THE INSUFFLATOR HAS A YOKE ON THE END WHICH ATTACHES TO THE CARBON DIOXIDE TANK. THE YOKE HAS A PIN INDEX SYSTEM WHICH IS ONLY SUPPOSED TO BE ABLE TO BE CONNECTED TO THE CARBON DIOXIDE TANK. THE MFR'S REP, WHO FELT THAT THE NURSE MAY HAVE FORCED THE CONNECTION, REPLACED THE PIN INDEX. THE MFR'S REP WAS ASKED TO MAKE THE CONNECTION OF THE YOKE TO THE NITROGEN TANK; THE RPTR STATED THAT HE WAS ABLE TO DO IT WITHOUT FORCING THE PARTS TOGETHER.INFO SUBMITTED AS FOLLOW-UP 1/25/95: THE RPTR HEARD FROM THE MFR WHO ACKNOWLEDGED THAT THE PINS ON THE YOKE ARE TOO SHORT. APPROPRIATE MODIFICATIONS ARE BEING MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSUFFLATOR FCX RICHARD WOLF MEDICAL INSTRUMENTS CORP. 2054.00

    Patients

    Seq Age Sex Outcome Treatment
    1 *