BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION ELECTRONIC CONCERVER

    MDR report key: 6603059 · Received May 31, 2017

    Report

    Report Number
    1062191-2017-00004
    Event Type
    Injury
    Date Received
    May 31, 2017
    Report Date
    August 14, 2015
    Manufacturer
    INOVO. INC
    Product Code
    NFB
    UDI-DI
    00814470020198
    PMA / PMN Number
    K103392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REPORTED IN THIS EVENT (CONSERVER, OXYGEN, PRODUCT CODE: NFB, MODEL NUMBER: CM-904J, SERIAL NUMBER:(B)(4)) WAS RECEIVED ON 12/14/2015 AT ENOVORS MANUFACTURING FACILITY IN (B)(4). THE DEVICE WAS TESTED USING THE DEVICE CONTROL PLAN 755. ET WAS DETERMINED THAT THE PIEZO (FESTO) VALVE (PART NUMBER: 3000412) WAS DEFECTIVE AND WAS CAUSING THE DEVICE TO NOT PULSE. IN ADDITION IT WAS NOTED THAT THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) (PART NUMBER: 4000276-ALARM) WAS DAMAGED, BUT EVEN WITH THE DAMAGED PCBA, THERE WAS STILL ELECTRICAL POWER TO THE VALVE. THE PIEZO (FESTO) VALVE AND PCBA WERE REPLACED AND THE DEVICE PERFORMED TO SPECIFICATIONS AS DESCRIBED IN THE DEVICE CONTROL PLAN 755. ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL, SO A CAUSAL RELATIONSHIP BETWEEN THE DEVICE MALFUNCTION AND THE NECESSITY TO TRANSPORT THE PATIENT TO THE HOSPITAL COULD NOT BE MADE. THE DEVICE IS NOT INTENDED FOR TREATMENT OR DIAGNOSIS OF DISEASE PROCESS. IN ADDITION, THE DEVICE IS NOT INTENDED TO BE LIFE SAVING OR LIFE SUSTAINING, BUT TO PROVIDE SUPPLEMENTAL OXYGEN TO THE PATIENT. THE DEVICE HAS A FEATURE WHERE THE PATIENT CAN BYPASS THE CONSERVE MODE TO CONTINUOUS FLOW. THE BYPASS PREVENTS THE PATIENT FROM RECEIVING NO OXYGEN IF CONSERVE MODE IS NOT FUNCTIONING. [T IS UNKNOWN IF THE PATIENT ATTEMPTED TO USE CONTINOUS FLOW. (B)(4). THIS MDR IS BEING 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 [NOVO 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 [NOVO 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 REPORTED THAT THE PATIENT WAS NOT RECEIVING OXYGEN WHILE IN THE CONSERVE MODE AND THE DEVICE IS DISPLAYING A CONSTANT BLINKING LIGHT. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR AN UNKNOWN REASON. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. MULTIPLE ATTEMPTS TO GATHER ADDITONAL INFORMATION WERE UNSUCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384040 EVOLUTION ELECTRONIC CONCERVER EVOLUTION ELECTRONIC CONCERVER NFB INOVO. INC OM-904J 00814470020198

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention