BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS 300

    MDR report key: 1253445 · Received December 5, 2008

    Report

    Report Number
    1825511-2008-00016
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    PLAINFIELD-LOX-RX
    Product Code
    BYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. ONLY NON-DESTRUCTIVE TESTING WAS PERFORMED. THE DEVICE WAS FOUND TO BE USED AND SOILED. UPON VISUAL INSPECTION, THE FEMALE QUICK CONNECT WAS FOUND TO BE WORN AND LOOSE. ALL OTHER VISIBLE COMPONENTS APPEARED NORMAL. THE FILL TEST YIELDED NO VISIBLE INDICATIONS OF VAPOR OR LIQUID OXYGEN LEAKING FROM THE UNIT. THE CONTENTS INDICATOR OPERATED WITHIN SPECIFICATIONS. THE NORMAL EVAPORATION RATE WAS WITHIN NORMAL LIMITS. THE PRESSURE HOLD TEST, FIRST HOUR EVAPORATION TEST AND THE PRIMARY RELIEF VALVE PRESSURE WERE NOT WITHIN SPECIFICATION. THE FUNCTIONAL TEST COULD NOT BE COMPLETED DUE TO A SIGNIFICANT PRESSURE LEAK OF UNK ORIGIN. IN AN ATTEMPT TO DUPLICATE THE REPORTED PROBLEM, THE DEVICE WAS FILLED TO CAPACITY WITH LIQUID OXYGEN, PLACED IN THE HORIZONTAL POSITION AND OBSERVED 10 MINUTES FOR SIGNS OF LEAKAGE. THE UNIT WAS THEN EMPTIED AND IMMEDIATELY REFILLED TO SIMULATE FILLING THE UNIT IN WORST CASE SCENARIO. AFTER THE SECOND FILL, THE DEVICE PRODUCED VAPOR AND LIQUID LEAKS AT THE FEMALE QUICK CONNECT LIP SEAL CONNECTION AND AT THE VENT VALVE RECESS AND LEVER. WHEN PLACED IN THE HORIZONTAL POSITION, THE UNIT PRODUCED A CONTINUOUS VOLUME OF LIQUID OXYGEN THAT COLLECTED BENEATH AND AROUND THE PERIMETER OF THE UNIT. THE LEAK CONTINUED FOR 12 MINS WITHOUT INTERRUPTION BEFORE DISSIPATING. THE UNIT DID NOT SUCCESSFULLY COMPLETE THE NON-DESTRUCTIVE TESTING. WE WERE ABLE TO DUPLICATE THE REPORTED PROBLEM WHEN THE DEVICE WAS RE-FILLED UNDER COLD CONDITIONS. THE LIP SEAL LEAK IS CAUSED BY WEAR AND DEFORMATION. THE VAPOR/LIQUID LEAK EXPERIENCED AT THE VENT VALVE RECESS/LEVER IS TYPICALLY CAUSE B YA LOOSE VENT VALVE AT THE V-BLOCK CONNECTION. THE INVESTIGATION WAS UNABLE TO DETERMINE THE EXACT SOURCE OF THE LEAK WITHOUT DISASSEMBLING THE DEVICE. PRODUCT MANUAL WARNS. "DO NOT TOUCH LIQUID OXYGEN OR PARTS THAT HAVE BEEN IN CONTACT WITH LIQUID OXYGEN. LIQUID OXYGEN IS EXTREMELY COLD (-297 DEGREES FAHRENHEIT/ -183 DEGREES CELSIUS). WHEN TOUCHED, LIQUID OXYGEN, OR PARTS OF THE EQUIPMENT THAT HAVE BEEN CARRYING LIQUID OXYGEN, CAN FREEZE SKIN AND BODY TISSUE." TECHNICAL MANUAL PRE-FILL INSTRUCTIONS STATE, "VISUALLY INSPECT THE H300 UNIT FOR OVERALL INTEGRITY (FOR EXAMPLE, CRACKED, OR DAMAGED COMPONENTS). VERIFY THAT THE FILL CONNECTOR POPPET IS NOT WORN, LEAKING, OR DAMAGED. INSPECT THE CIRCULAR, WHITE LIP SEAL IN THE FILL CONNECTOR FOR CRACKS OR SIGNS OF WEAR."

    Description of Event or Problem · 1

    IT WAS REPORTED: A PATIENT WAS USING AN H300 PORTABLE LIQUID OXYGEN DEVICE WHILE DRIVING A CAR. THE DEVICE WAS LAYING IN THE SEAT NEXT TO THE PATIENT WHEN IT STARTED TO LEAK LIQUID OXYGEN. THE PATIENT MOVED THE DEVICE TO THE FLOOR OF THE VEHICLE. SOME TIME AFTER THE INCIDENT, THE PATIENT NOTICED PAIN ON HIS HIP WHERE THE UNIT HAD LEAKED ONTO HIM. THE PATIENT RECEIVED MEDICAL TREATMENT OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIOS 300 PORTABLE LIQUID OXYGEN DEVICE BYJ PLAINFIELD-LOX-RX H300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention