BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOXBOXI

    MDR report key: 12059502 · Received June 24, 2021

    Report

    Report Number
    1000448358-2021-00010
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 24, 2021
    Manufacturer
    NOXBOX LTD
    Product Code
    MRN
    PMA / PMN Number
    K201339
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON RETURN TO (B)(4), THE DEVICE WAS QUARANTINED, DECONTAMINATED, AND VISUALLY INSPECTED ACCORDING TO INCOMING DEVICE PROCEDURES. AFTER THE DEVICE WAS CHARGED ON DIFFERENT POWER BRICKS AND CABLES, IT WAS CONFIRMED THAT THE DEVICE DID NOT POWER BACK ON. WHEN THE DEVICE WAS OPENED, SIGNIFICANT EVIDENCE OF WATER INGRESS INTO THE DEVICE WAS FOUND, WHICH THEN RESULTED IN A LEAK ONTO THE POWER BOARD, SHORTING OUT AND DAMAGING THE BOARD. A REVIEW OF THE DEVICE LOG FILES INDICATED THAT THERE WERE MULTIPLE ¿WATER TRAP FULL¿ ALARMS ISSUED PRIOR TO THE EVENT THAT DO NOT APPEAR TO HAVE BEEN ADDRESSED BY THE USER; SPECIFICALLY DRAINING THE WATER TRAP TO CLEAR THE ALARM. AFTER REPLACING THE DAMAGED POWER BOARD, THE UNIT OPERATED NORMALLY AND WILL BE RETURNED TO SERVICE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL AT (B)(6) HOSPITAL REPORTED THAT A NOXBOXI DEVICE SHUT DOWN WHILE ON A PATIENT. THE PATIENT DESATURATED WHICH TRIGGERED THE THERAPIST TO ASSESS THE SITUATION WHERE THEY FOUND THE NOXBOXI DEVICE TO BE COMPLETELY POWERED OFF. ATTEMPTS TO POWER THE DEVICE BACK ON WHERE NOT SUCCESSFUL. THE DEVICE WAS REPLACED WITH A BACK-UP DEVICE AND THE PATIENT'S SATURATION LEVEL RETURNED. NO OTHER PATIENT INFORMATION WAS PROVIDE ON ATTEMPTS TO CONTACT THE HOSPITAL. THE DEVICE WAS STATED TO HAVE BEEN PLUGGED INTO A RED COLORED (GENERATOR PROTECTED) POWER OUTLET AND THE SOLID BLUE LIGHT ON IN THE BACK OF THE DEVICE INDICATED IT WAS RECEIVING POWER. PATIENT WAS ON A HFNC VENTILATOR SET TO 2 LPM AND 100% O2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954424 NOXBOXI NITRIC OXIDE ADMINISTRATION APPARATUS MRN NOXBOX LTD NOXBOXI

    Patients

    Seq Age Sex Outcome Treatment
    1 NOXIVENT| OXYGEN USP