BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXAIR GRAB 'N GO III

    MDR report key: 5917221 · Received August 31, 2016

    Report

    Report Number
    1000448358-2016-00003
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    July 28, 2016
    Report Date
    August 30, 2016
    Manufacturer
    PRAXAIR HEALTHCARE SERVICES (SPEC DEVELOPER)
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATIONS BY PRAXAIR IT HAS BEEN DETERMINED THIS UNIT WAS DAMAGED, AND THAT DAMAGE WAS NOT CONSISTENT WITH NORMAL WEAR AND TEAR. WE BELIEVE THIS IS AN ISOLATED INCIDENT BECAUSE OF THE FOLLOWING: A REVIEW OF THE PRAXAIR CUSTOMER COMPLAINTS AND NON CONFORMANCES WAS CONDUCTED AND THERE HAVE BEEN NO SIMILAR REPORTED INCIDENTS FOR GRAB 'N GO III MODELS OVER THE LAST YEAR. THE CUSTOMER ADMITTED TO NOT FOLLOWING OPERATING INSTRUCTIONS. THE GRAB 'N GO III UNITS ARE CHECKED FOR FLOW ON AN ANNUAL BASIS TO ENSURE NORMAL FUNCTIONING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2016 THAT A GRAB 'N GO III OXYGEN UNIT FAILED TO DELIVER A FLOW OF OXYGEN TO A PATIENT WHEN THE UNIT WAS TURNED ON. THE ADMINISTRATOR ACKNOWLEDGED THE DEVICE WAS CONNECTED TO THE PATIENT PRIOR TO PERFORMING THE VERIFICATION OF FLOW TEST, WHICH IS INCONSISTENT WITH THE INSTRUCTIONS IN THE USER MANUAL. THE UNIT WAS BEING USED ON A PATIENT THAT WAS IN TRANSPORT WITHIN THE HOSPITAL. THERE WAS NO INJURY TO THE PATIENT. ANOTHER GRAB 'N GO III OXYGEN UNIT WAS OBTAINED AND USED TO ADMINISTER OXYGEN TO THE PATIENT DURING TRANSPORT WITHOUT ISSUE. THE GRAB 'N GO III IS A CLASS I VALVE INTEGRATED PRESSURE REGULATING DEVICE, WHICH IS INSTALLED ONTO A STEEL HIGH PRESSURE MEDICAL OXYGEN USP CYLINDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569177 PRAXAIR GRAB 'N GO III REGULATOR, PRESSURE, GAS CYLINDER CAN PRAXAIR HEALTHCARE SERVICES (SPEC DEVELOPER) PRX-9369

    Patients

    Seq Age Sex Outcome Treatment
    1