BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCENTRATOR, DRIVE, OCI

    MDR report key: 6605143 · Received June 1, 2017

    Report

    Report Number
    1062191-2017-00006
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Report Date
    August 5, 2015
    Manufacturer
    INOVO. INC
    Product Code
    CAW
    PMA / PMN Number
    K080391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REPORTED IN THIS EVENT (PURE OXYGEN CONCENTRATOR, PRODUCT CODE: CAW, MODEL CH5000S, SERIAL NUMBER: (B)(4)) WAS RECEIVED ON 08/05/2015 AT INOVO'S MANUFACTURING FACILITY IN (B)(4). DURING THE VISUAL INSPECTION IT WAS NOTED THAT THE DEVICE HAD A BROKEN COMPRESSOR TROMBONE ASSEMBLY AND THAT THE DEVICE HED EXCEEDED THE MAXIMUM AMOUNT OF USE HOURS AND WAS SCRAPPED. THE EVIDENCE OF OVERHEAT WAS NOTED DURING VISUAL INSPECTION. THERE WERE NO REPORTED OVERHEAT CONDITIONS, NOR ANY ADVERSE PATIENT EFFECTS. THE DEVICE HISTORY FILE WAS REVIEWED AND THERE WERE NO NONCONFORMATIES OR ISSUES DURING THE MANUFACTURING PROCESS. THIS MDR IS BEING SUBMITTED BASED 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 IS BEING 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 01/28/2017 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 ORIGINALLY REPORTED THAT THE DEVICE WAS EXCESSIVELY NOISY. DURING TESTING AND INVESTIGATION, IT WAS NOTED THAT THE DEVICE WAS OVERHEATING CAUSING HEAT DAMAGE TO COMPRESSOR HOUSING AND UNIT OUTER SURFACE. IT WAS ALSO NOTED THAT THE DEVICE HAD EXCEEDED MAXIMUM USE HOURS AND WAS SCRAPPED, THERFORE THERE WAS NO FAULT ISOLATION. THIS WAS AN OUT OF BOX FAILURE, THERE WAS NO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387696 CONCENTRATOR, DRIVE, OCI CONCENTRATOR, DRIVE, OCI CAW INOVO. INC CH5000S

    Patients

    Seq Age Sex Outcome Treatment
    1