BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONAIRE

    MDR report key: 7520173 · Received May 16, 2018

    Report

    Report Number
    3004972304-2018-00016
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 14, 2018
    Report Date
    August 8, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K872534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISIONAIRE STATIONARY CONCENTRATOR IN QUESTION WAS NOT EVALUATED DIRECTLY. INVESTIGATION OF THE ADVERSE EVENT WAS CONDUCTED USING A HISTORICAL ANALYSIS. REFER TO CAPA (B)(4). BASED ON THE INCIDENT DESCRIPTION IN THE ADVERSE EVENT FORM, THE VISIONAIRE UNIT'S FINAL PART NUMBER, AS098-1, AND THE VISIONAIRE UNIT'S SERIAL NUMBER, (B)(4), IT WAS DETERMINED THAT THE ADVERSE EVENT FALLS WITHIN THE PURVIEW OF CAPA (B)(4). THE CAPA ADDRESSES INCIDENTS IN WHICH FLUID ENTERING THE CONCENTRATOR UNIT CAUSED THE UNIT'S ON/OFF SWITCH TO SHORT. THE RELATED INVESTIGATION POINTED TO IMPROPER CLEANING CAUSING FLUID TO ENTER THE UNIT AND COME IN CONTACT WITH THE ON/OFF SWITCH. THE CAPA DETERMINED THAT THE RISK FACTOR IS LOW AND SEVERAL ACTIONS WERE TAKEN TO MITIGATE THE FAILURE.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UNIT WAS RUNNING ON PATIENT. THEN STARTED ALARMING. THE UNIT SMELLED LIKE IT WAS BURNING. THE NURSE SWAPPED IT OUT FOR A DIFFERENT UNIT. THE UNIT WAS SITTING IN A HALL UNPLUGGED AND OBSERVED TO BE SMOKING. THE NURSE WHEELED THE UNIT OUTSIDE DURING WHICH A SMALL FLAME APPEARED AT THE SWITCH. THE FLAME WAS EXTINGUISHED WITH EXTINGUISHER. UNIT WAS RAINED ON AFTER EVENT WHILE OUTSIDE. THE WHOLE SCENARIO TOOK ABOUT 5 MINS. THE TECH IS UNSURE IF THE UNIT MALFUNCTIONED OR IF EXCESSIVE CLEANING SOLUTION MAY HAVE CAUSED THE SWITCH TO SHORT OUT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363244 VISIONAIRE OXYGEN CONCENTRATOR, STATIONARY CAW CAIRE INC. AS098-1

    Patients

    Seq Age Sex Outcome Treatment
    1