BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOTUS ELECTRONIC CONSERVER

    MDR report key: 6602603 · Received May 31, 2017

    Report

    Report Number
    1062191-2017-00002
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Report Date
    September 22, 2015
    Manufacturer
    INOVO INC.
    Product Code
    NFB
    PMA / PMN Number
    K042142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REPORTED IN THIS EVENT (CONSERVER, OXYGEN, PRODUCT CODE: NFB, MODEL OM-700A, SERIAL NUMBER: (B)(4)) WAS RECEIVED AT INOVO'S MANUFACTURING FACILITY IN (B)(4). THIS DEVICE WAS TESTED AND ANALYZED USING THE DEVICE CONTROL PLAN 181. THE CONSERVER HAS VISIBLE BURN MARKS AT THE INLET OF THE YOKE. THE CYLINDER/POST VALVE WAS NOT RECOVERED BY THE CUSTOMER, SO EVALUATION COULD NOT BE DONE. VISIBLE RESIDUE WAS NOTED ALONG THE TOP SIDE OF THE FLANGE AND SIDES OF THE BRASS INLET FILTER. NO RESIDUE IS VISIBLE IN THE SINTERED INLET FILTER OF THE BRASS INSERT. THE SEAL WASHER WAS COMPLETELY DISINTEGRATED LEAVING ONLY REMNANTS OF THE BRASS RING. THERE WERE NO OTHER BURN MARKS ON THE EXTERIOR OF THE UNIT. THERE ARE SCUFF MARKS FOUND ON THE YOKE, PRESSURE GAUGE, KNOB SELECTOR, AND OUTLET BARB, INDICATING THAT THE DEVICE MAY HAVE BEEN DROPPED OR MISHANDLED. ANALYSIS INDICATED THAT FLOW FRICTION WAS MOST LIKELY THE CAUSE, DUE TO A POOR CONNECTION BETWEEN THE CONSERVER AND TANK. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED BASED ON THE FACT THAT NO SEAL WASHER WAS SUBMITTED. THE INSTRUCTIONS FOR USE (IFU) STATES TO INSPECT THE SEALING SURFACES OF THE OXYGEN CYLINDER AND THE CONSERVER FOR CONTAMINATION AND DAMAGE PRIOR TO CONNECTING. THE IFU HAS VISUAL AIDS TO ASSIST IN DISPLAYING A PROPER CONNECTION. IN ADDITION, THE IFU STATES THAT ONLY ONE RECONNECTION SHOULD BE ATTEMPTED. IF A SECOND ATTEMPT TO CONNECT THE DEVICE FAILS, THE PATIENT IS INSTRUCTED TO NOT USE THE DEVICE AND CONTACT THE COMPANY THEY PURCHASED THE UNIT FROM. THIS MDR WAS SUBMITTED AS A RESULT OF A VOLUNTARY TWO-YEAR RETROSPECTIVE REVIEW THAT WAS PERFORMED TO IDENTIFY POTENTIALLY REPORTABLE COMPLAINTS. THERE WAS NO REPORT THAT AN INOVO DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT WHERE DEATH, SERIOUS INJURY, OR A SIGNIFICANT PUBLIC HEALTH HAZARD HAS OCCURRED OR MAY OCCUR IF THE ALLEGED MALFUNCTION WERE TO REOCCUR; HOWEVER, THIS EVENT WAS REPORTED IN AN ABUNDANCE OF CAUTION. IF INOVO BECOMES AWARE OF ADDITIONAL INFORMATION THAT WOULD AFFECT REPORTABILITY, A SUPPLEMENTAL WILL BE SUBMITTED. NOTE THAT THIS MDR WAS PREVIOUSLY SUBMITTED ON 09/06/2016 AND IS BEING RE-SUBMITTED BECAUSE IT WAS NOT FULLY PROCESSED OR RECEIVED BY FDA DUE TO AN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A VEHICLE WITH THE CYLINDER RESTRAINED ON THE BACK SEAT OF THE VEHICLE AND THE CYLINDER VALVE WAS TURNED ON. SMOKE WAS SMELLED AND A BIG BANG WAS HEARD. THE CYLINDER VALVE WAS TURNED OFF, BUT JUST BEFORE TURNING IT OFF, IT WAS OBSERVED THAT THE CYLINDER WAS MAKING A LOUD NOISE FROM THE OXYGEN BEING RELEASED. NO ONE WAS SMOKING AT THE TIME, ALTHOUGH BOTH THE PATIENT AND PARTNER ARE SMOKERS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382929 LOTUS ELECTRONIC CONSERVER CONSERVER, OXYGEN, NFB INOVO INC. OM-700A

    Patients

    Seq Age Sex Outcome Treatment
    1