BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOXBOXI

    MDR report key: 11684590 · Received April 19, 2021

    Report

    Report Number
    1000448358-2021-00008
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 16, 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

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED BY IMPORTER.

    Description of Event or Problem · 1

    PATIENT AT (B)(6) HOSPITAL WAS BEING TRANSPORTED FROM THE NICU UNIT FOR AN MRI WHEN THE NOXBOXI DEVICE SCREEN WENT BLACK/BLANK WITH AN APPARENT DEAD BATTERY. PATIENT WAS ON 20PPM NO. THERE WAS NO LOW BATTERY ALARM ISSUED BY THE DEVICE PRIOR TO THE EVENT. DRAEGER V-500 VENTILATOR WAS BEING USED WITH VENT SETTINGS OF: SIMV-VG, SET RATE 26, VT 20 (6 ML/KG), PEEP+8CMH2O, PS 8CMH2O, TI 0.6, FIO2 0.4. NO PATIENT HARM WAS REPORTED AS THE PATIENTS FIO2 REMAINED STABLE UNTIL THE DEVICE COULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581064 NOXBOXI NITRIC OXIDE ADMINISTRATION APPARATUS MRN NOXBOX LTD NOXBOXI

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO