BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 15550733 · Received October 6, 2022

    Report

    Report Number
    2438477-2022-00082
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    July 13, 2022
    Report Date
    November 16, 2023
    Manufacturer
    VEGA TECHNOLOGIES INC.
    Product Code
    CAF
    UDI-DI
    00822383504131
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) HEALTHCARE PREVIOUSLY REPORTED IN SECTION B5 OF RECEIVING A MEDWATCH REPORT REGARDING AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR, WHICH STATES "PATIENT SMOKING WITH OXYGEN ON AND SUSTAINED SECOND DEGREE BURNS TO FACE." THERE IS NO STATEMENT OR EVIDENCE IN THE REPORT SUGGESTING THE OXYGEN CONCENTRATOR MALFUNCTIONED OR IN ANY WAY CAUSED OR CONTRIBUTED TO THE PATIENT INJURY. THE UNIT WAS RETURNED TO (B)(6) FOR EVALUATION, AND THE EVIDENCE INDICATES THE ROOT CAUSE OF THE THERMAL DAMAGE TO THE UNIT WAS THE RESULT OF AN EXTERNAL HEAT/FIRE SOURCE, WHICH IS CONSISTENT WITH THE REPORT OF THE PATIENT SMOKING WHILE USING THE OXYGEN CONCENTRATOR. THE UNIT WAS REPAIRED AND IS OPERATING TO SPECIFICATION." THIS WAS NOT THE CORRECT NARRATIVE FOR THIS SUBMISSION. THIS ISSUE WAS REPORTED ON MDR 2515872-2022-00112. THE CORRECT NARRATIVE FOR THIS ISSUE IS IN SECTION B5 OF THIS REPORT.

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE RECEIVED A MEDWATCH REPORT REGARDING AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR, WHICH STATES "PATIENT SMOKING WITH OXYGEN ON AND SUSTAINED SECOND DEGREE BURNS TO FACE." THERE IS NO STATEMENT OR EVIDENCE IN THE REPORT SUGGESTING THE OXYGEN CONCENTRATOR MALFUNCTIONED OR IN ANY WAY CAUSED OR CONTRIBUTED TO THE PATIENT INJURY. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION, AND THE EVIDENCE INDICATES THE ROOT CAUSE OF THE THERMAL DAMAGE TO THE UNIT WAS THE RESULT OF AN EXTERNAL HEAT/FIRE SOURCE, WHICH IS CONSISTENT WITH THE REPORT OF THE PATIENT SMOKING WHILE USING THE OXYGEN CONCENTRATOR. THE UNIT WAS REPAIRED AND IS OPERATING TO SPECIFICATION."

    Description of Event or Problem · 0

    (B)(6) HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING THE TUBING OF AN END USERS NEBULIZER BECOMING VERY WARM TO THE TOUCH. THE REPORTER OF THE INCIDENT INDICATED THAT THE END USER SUSTAINED A YEAST INFECTION IN HER THROAT WHICH BECAME BLISTERED. THE REPORTER OF THE INCIDENT INDICATED THAT IT WAS UNCLEAR IF THE INJURY WAS FROM THE MEDICINE OR A COMBINATION OF THE HEAT, WHICH THEY FELT WAS EXCESSIVE. THERE WAS NO INFORMATION REGARDING AN MEDICAL ATTENTION RECEIVED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AND ARRANGE FOR THE DEVICE TO BE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. (B)(6) HEALTHCARE BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. IF PERTINENT INFORMATION BECOMES AVAILABLE AT A LATER DATE, AN ADDENDUM TO THIS REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2859641 DRIVE NEBULIZER CAF VEGA TECHNOLOGIES INC. 18081 00822383504131

    Patients

    Seq Age Sex Outcome Treatment
    1 Female