BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXAIR VANTAGE

    MDR report key: 2539150 · Received April 4, 2012

    Report

    Report Number
    1000448358-2012-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Report Date
    March 12, 2012
    Manufacturer
    PRAXAIR, INC
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE RETURNED UNIT, THE CAP SCREW LOOSENED SUFFICIENTLY AND ALLOWED SEPARATION BETWEEN THE KNOB TOP AND THE KNOB BOTTOM TO SUCH A DEGREE THAT THE KEYING FEATURES BETWEEN THE TWO BECAME DISENGAGED, THEREBY ALLOWING FREE ROTATION OF THE TOP KNOB AND THE ORIFICE PLATE INDEPENDENT OF THE PRINTED KNOB BOTTOM. THIS FREE AND INDEPENDENT ROTATION OF THE TOP KNOB RESULTED IN MIS-INDEXING BETWEEN THE ACTUAL ORIFICE PLATE POSITION AND THE OBSERVED FLOW SETTING. ANALYSIS HAS CONCLUDED THAT THE FAILURE OF THE VANTAGE UNIT TO DISPENSE THE FLOW SELECTED AND VISIBLE IN THE VIEW WINDOW OF THE SHROUD WAS DUE TO THE FAILURE OF THE KNOB CAP SCREW TO RETAIN ITS ASSEMBLED TORQUE IN THE KNOB ASSEMBLY. ASSEMBLY PROCESS AT THE TIME OF MANUFACTURE SPECIFIED THE USE OF THREAD RETAINING COMPOUND. EXAMINATION FOUND NO EVIDENCE OF ANY RESIDUAL THREAD RETAINING COMPOUND PRESENT ON EITHER THE CAP SCREW MALE THREADS OR THE ORIFICE PLATE SHAFT FEMALE THREADS. IT IS UNK AS TO WHY THE SUBJECT UNIT DID NOT EXHIBIT ANY EVIDENCE OF THREAD RETAINING COMPOUND ON EITHER THE CAP SCREW OR ORIFICE PLATE SHAFT THREADS. THE ABSENCE OF THREAD RETAINING COMPOUND MAY HAVE BEEN A FACTOR IN THE LOSS OF RETENTION OF THE CAP SCREW.

    Description of Event or Problem · 1

    (B)(6) HOSPITAL REPORTED THAT A PRAXAIR GRAB'N GO VANTAGE UNIT DID NOT HAVE FLOW AT THE USE BARB WHEN THE FLOW SELECTOR KNOB WAS TURNED TO 25 LITERS PER MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRAXAIR VANTAGE REGULATOR, PRESSURE, GAS CYLINDER CAN PRAXAIR, INC PRX 500

    Patients

    Seq Age Sex Outcome Treatment
    1