BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOXBOXI NITRIC OXIDE DELIVERY SYSTEM

    MDR report key: 20481163 · Received October 18, 2024

    Report

    Report Number
    3012796317-2024-00006
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 18, 2024
    Manufacturer
    NOXBOX LTD
    Product Code
    MRN
    UDI-DI
    05060541640009
    PMA / PMN Number
    K231823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOG FILES WERE EXAMINED DURING SERVICING BY THE IMPORTER USING STANDARD PROCEDURES FOR EVALUATING PRODUCT PROBLEM DEVICES WITH NO ANOMALIES OR IRREGULAR USAGE NOTED WITHIN THE LOG. HOWEVER, REVIEW OF THE INCIDENT REPORT INDICATES THAT THIS WAS AN OFF-LABEL USE (ADULT PATIENT) BASED ON THE INDICATIONS APPROVED FOR THE NOXBOXI DEVICE. COMPREHENSIVE INVESTIGATION AND TESTING CONDUCTED BY THE IMPORTER REPLICATED THE DOSE FLUCTUATIONS, DELIVERY FAILURE, AND IDENTIFIED A MALFUNCTIONING MANIFOLD AS THE ROOT CAUSE. THE MANIFOLD WAS REPLACED, AND POST-SERVICE ASSESSMENT CONFIRMED ADHERENCE TO ALL MANUFACTURER SPECIFICATIONS. A THOROUGH REVIEW OF COMPLAINT FILES FOR THIS REPORTABLE CONDITION INDICATES THE ISSUE FALLS WITHIN ESTABLISHED CONTROL LIMITS. NO PREVIOUS SERVICING OR DEVICE HISTORY SUGGESTS A CONTRIBUTING FACTOR TO THE ISSUE. IT WAS NOTED THE MANIFOLD HAD BEEN RECALLED AND REMEDIATED IN RESPONSE TO THE 2023 RECALL INITIATED BY NOXBOX LTD.; HOWEVER, THIS MALFUNCTION IS UNRELATED. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    DARTMOUTH HITCHCOCK MEDICAL CENTER REPORTED THAT DURING INHALED NITRIC OXIDE (INO) THERAPY USING THE NOXBOXI DEVICE A PRODUCT PROBLEM OCCURRED WHERE THE DEVICE DELIVERED AN INCORRECT DOSE OF NO. THIS INCORRECT DOSE TRIGGERING NO HIGH AND LOW ALARMS. SUBSEQUENT TO THE INCORRECT DOSING, THE DEVICE ALARMED FOR "CRITICAL DELIVERY FAULT" AND CEASED TO DELIVER INO THERAPY. THE HOSPITAL STAFF RESPONDED PROMPTLY AND SUCCESSFULLY REPLACED THE NOXBOXI DEVICE. NO ADVERSE PATIENT OUTCOMES WERE OBSERVED. VENTILATOR: SERVO-U. VENTILATOR SETTINGS: SIMV (VC) + PS , FIO2 60%, VT 750, PEEP 10, RATE 25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744569 NOXBOXI NITRIC OXIDE DELIVERY SYSTEM NOXBOXI MRN NOXBOX LTD 05060541640009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOXIVENT.