BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONOX NITRIC OXIDE DELIVERY DEVICE

    MDR report key: 8027390 · Received November 1, 2018

    Report

    Report Number
    8027390
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 23, 2018
    Report Date
    October 25, 2018
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF PATIENT TRANSPORT, THE UNIT DID NOT STAY ON BATTERY POWER DESPITE BEING CHARGED. NURSE WAITED UNTIL THE HELICOPTER POWERED UP AND CONNECTED THE UNIT TO MAIN'S POWER AND THE UNIT CAME BACK ON AND OPERATIONAL. UNIT UNDER INVESTIGATION, HAD THE BATTERY REPLACED BY THE MANUFACTURER ON (B)(4) 2018 AND IT WAS ALSO REPAIRED BY THEM ON (B)(4) 2018. MANUFACTURER RESPONSE FOR APPARATUS, NITRIC OXIDE DELIVERY, AERONOX NITRIC OXIDE DELIVERY DEVICE (PER SITE REPORTER). MANUFACTURER INFORMED BY PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867346 AERONOX NITRIC OXIDE DELIVERY DEVICE APPARATUS, NITRIC OXIDE DELIVERY MRN INTERNATIONAL BIOMEDICAL, LTD. AERONOX

    Patients

    Seq Age Sex Outcome Treatment
    1