BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAB N' GO

    MDR report key: 24998284 · Received April 27, 2026

    Report

    Report Number
    3012160128-2026-00005
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 24, 2026
    Manufacturer
    LINDE GAS & EQUIPMENT
    Product Code
    ECX
    UDI-DI
    00850009834102
    PMA / PMN Number
    K132778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, AND FUNCTIONAL TESTING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. THE EVALUATION CONFIRMED THAT THE REGULATOR TRANSITIONS INTO AND OUT OF FILL MODE AS DESIGNED AND THAT NO LEAKS OR FUNCTIONAL ABNORMALITIES WERE IDENTIFIED. BASED ON THE RESULTS OF THE EVALUATION AND REVIEW OF THE AVAILABLE INFORMATION, THE DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATION AT THE TIME OF TESTING. THE REPORTED CONDITION, IN WHICH THE REGULATOR WAS OBSERVED IN FILL MODE DURING USE, IS CONSISTENT WITH INADVERTENT ACTIVATION OF THE FILL MODE CONTROL DURING HANDLING OR OPERATION. NO DEVICE MALFUNCTION WAS IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    (E)(1) REPORTED THAT A PATIENT RECEIVING SUPPLEMENTAL OXYGEN FROM A PORTABLE OXYGEN CYLINDER EQUIPPED WITH A GRAB N' GO REGULATOR. THE REGULATOR WAS REPORTEDLY SET TO DELIVER OXYGEN AT 4 L/MIN. DURING USE, THE CYLINDER INDICATED IT WAS IN FILL MODE, AND THE PRESSURE INDICATOR DISPLAYED APPROXIMATELY 43 PSI. NO AUDIBLE ALARM WAS TRIGGERED. THE PATIENT WAS OBSERVED TO HAVE DECREASED OXYGEN SATURATION TO 83% AND WAS REPORTED TO BE HYPOXIC. IN RESPONSE, OXYGEN THERAPY WAS INCREASED TO 6 L/MIN VIA NASAL CANNULA, RESULTING IN THE PATIENT VITALS RETURNING TO PRE-EVENT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161159 GRAB N' GO GRAB 'N GO DIGITAL ECX LINDE GAS & EQUIPMENT MVA2UOS011 00850009834102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention OXYGEN