BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOX RELIEVE

    MDR report key: 8105750 · Received November 27, 2018

    Report

    Report Number
    9610861-2018-00001
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    April 20, 2018
    Report Date
    November 27, 2018
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES INC.
    Product Code
    BZR
    PMA / PMN Number
    K113687
    Removal / Correction Number
    9610861-5/10/2018-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REPORTING OF A COMPLAINT (DEVICE MALFUNCTION DURING SERVICE) THAT WAS RECEIVED ON APR.20, 2018. A VOLUNTARY PRODUCT CORRECTION FOR UPGRADE WAS PROPOSED AND THE CORRECTION/REMOVAL REPORT HAS BEEN SENT TO FDA ON MAY 10, 2018. HOWEVER, EMDR HAS NOT BEEN FILED AT THAT TIME.

    Description of Event or Problem · 1

    ON APR.24, 2018 WE RECEIVED TWO (2) O2/N2O MIXERS (SERIAL NUMBERS: (B)(4)) WHICH WERE REPORTED TO HAVE DELIVERED HIGHER LEVELS OF NITROUS OXIDE THAN SPECIFICATION DURING ROUTINE TESTING. OUR RECORDS SHOW THAT NEITHER OF THESE UNITS HAD BEEN RETURNED FOR SERVICE SINCE THEY WERE MANUFACTURED IN 2014. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT IN EITHER CASE. AS THE DEVICE IS INTENDED TO DELIVER A 50/50% MIXTURE OF NITROUS OXIDE AND OXYGEN TO A PATIENT, THE POTENTIAL DELIVERY OF HIGHER NITROUS OXIDE CONCENTRATIONS WHICH MAY AFFECT OXYGEN SATURATION LEVELS OF THE PATIENT. HOWEVER, AS THE DEVICE DELIVERS A SELF-ADMINISTERED (BASED ON PATIENT DEMAND) A MIXTURE OF NITROUS OXIDE AND OXYGEN AND IT IS HANDHELD BY THE PATIENT AND NOT ATTACHED TO THEM, THE DEVICE WOULD STOP SUPPLYING GAS WHEN THE MASK TO FACE SEAL IS BROKEN. HENCE, THE PROBABILITY OF THIS ISSUE CREATING A HEALTH HAZARD IS, BASED ON OUR HAZARD EVALUATION, EXTREMELY LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948303 EQUINOX RELIEVE N2O/O2 MIXER BZR O-TWO MEDICAL TECHNOLOGIES INC. 01EQ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other