BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXIAR GRAB 'N GO III

    MDR report key: 3770314 · Received February 18, 2014

    Report

    Report Number
    1000448358-2014-00002
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    February 13, 2014
    Manufacturer
    PRAXAIR HEALTHCARE
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON TESTING, THE REGULATOR EXHIBITED INCONSISTENT AND UNSTABLE FLOW RATES AT THE VARIOUS FLOW POSITIONS WHEN ROTATING THE KNOB IN BOTH THE ASCENDING OR DESCENDING DIRECTIONS. UPON DISASSEMBLY, IT WAS NOTED THAT THERE WS NO EVIDENCE OF INTERNAL MOISTURE IN THE REGULATOR AND THE ORIFICE PLATE ROTATED FREELY WITHIN THE HOUSING. THE POSITIONAL RELATIONSHIP WAS FOUND TO BE GOOD BETWEEN THE KNOB SHAFT, ORIFICE PLATE, FLOW CONTROL HOUSING, AND THE BODY. FURTHER INSPECTION OF THE FLOW CONTROL MECHANISM FOUND THE ELASTOMER COMPRESSION SLEEVE, WHICH PROVIDES THE SEAL BETWEEN THE HOUSING AND THE ORIFICE PLATE, TO BE DISTORTED OR PARTIALLY COLLAPSED. WHEN THIS OCCURS, THE SEAL BETWEEN THE HOUSING AND THE ORIFICE LOCATIONS ON THE PLATE CAN BECOME MISALIGNED, RESULTING IN FLOW RESTRICTION AND/OR VARIABILITY AT THE DETENT FLOW POSITIONS. AFTER DISASSEMBLY AND REMOVAL FROM THE HOUSING, THE COMPRESSION SLEEVE RETURNED CLOSER TO ITS ORIGINAL SHAPE. ANALYSIS HAS SHOWN THAT THIS FAILURE MODE IS OF A DELAYED AND INTERMITTENT NATURE AND CYCLING THE FLOW CONTROL KNOB HAS CAUSED THE UNIT TO RESUME NORMAL OPERATIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) THAT IS AS FOLLOWS: WHILE PERFORMING A TEST ON AN OXYGEN CYLINDER WITH A VALVE INTEGRATED PRESSURE REGULATING DEVICE THAT WAS IN INVENTORY, THE UNIT APPARENTLY DID NOT PROVIDE THE CORRECT FLOW OF OXYGEN AT THE FLOW SETTING. THE UNIT WAS NOT IN USE AT THE TIME OF TEST. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102041 PRAXIAR GRAB 'N GO III REGULATOR, PRESSURE, GAS CYLINDER CAN PRAXAIR HEALTHCARE PRX-9369 0904332280

    Patients

    Seq Age Sex Outcome Treatment
    1