BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 5866759 · Received August 10, 2016

    Report

    Report Number
    2438477-2016-00036
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    June 28, 2016
    Report Date
    December 11, 2018
    Manufacturer
    SHENZHEN HOMED MEDICAL DEVICE CO LTD
    Product Code
    CAF
    UDI-DI
    00822383264851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DRIVE MEDICAL RECEIVED NOTIFICATION OF AN INCIDENT FROM A PATIENT USING A NEBULIZER THAT DRIVE MEDICAL IMPORTS AND DISTRIBUTES. THE END USER WAS USING THE NEBULIZER (18070) ALLEGEDLY WHEN THE MOTOR BECAME INCREASINGLY LOUDER AND STARTED VIBRATING. SHE POWERED THE NEBULIZER ON/OFF AND NO AIR FLOW WAS BEING PRODUCED. SHE WAS TAKEN TO HARTFORD HOSPITAL WHERE SHE STAYED FOR 2 DAYS. THE END USER STATED SHE IS FINE NOW BUT, WOULD LIKE A REPLACEMENT UNIT. ROOT CAUSE AND INVESTIGATION UPDATE: THE UNIT WAS RETURNED UNDER RMA #60279426 AND WAS EVALUATED BY A MEMBER OF THE QE DEPARTMENT. THE EVALUATION REPORT STATES THAT THE ROOT CAUSE OF THIS DEFECT CAN BE ATTRIBUTED TO THE FACT THAT THE ECCENTRIC GEAR ON THE MOTOR WAS ASSEMBLED TOO CLOSE TO THE CONNECTING ROD, CREATING FRICTION AND CREATING THE BLACK POWDER. BASED ON THE INVESTIGATION, THE ISSUE DESCRIBED IN THIS COMPLAINT HAS ALREADY BEEN ADDRESSED IN SCAR 58 (WHICH AFFECTED BOTH 18070 &18080). THE CHANGES WERE IMPLEMENTED IN (B)(6) 2015. THE SERIAL NUMBER OF THE UNIT IN QUESTION (B)(6) PREDATES THESE CHANGES.

    Description of Event or Problem · 0

    DRIVE MEDICAL RECEIVED NOTIFICATION OF AN INCIDENT FROM A PATIENT USING A NEBULIZER THAT DRIVE MEDICAL IMPORTS AND DISTRIBUTES. THE END USER WAS USING THE NEBULIZER (18070) ALLEGEDLY WHEN THE MOTOR BECAME INCREASINGLY LOUDER AND STARTED VIBRATING. SHE POWERED THE NEBULIZER ON/OFF AND NO AIR FLOW WAS BEING PRODUCED. SHE WAS TAKEN TO HARTFORD HOSPITAL WHERE SHE STAYED FOR 2 DAYS. THE END USER STATED SHE IS FINE NOW BUT, WOULD LIKE A REPLACEMENT UNIT. ROOT CAUSE AND INVESTIGATION UPDATE: THE UNIT WAS RETURNED UNDER RMA #60279426 AND WAS EVALUATED BY A MEMBER OF THE QE DEPARTMENT. THE EVALUATION REPORT STATES THAT THE ROOT CAUSE OF THIS DEFECT CAN BE ATTRIBUTED TO THE FACT THAT THE ECCENTRIC GEAR ON THE MOTOR WAS ASSEMBLED TOO CLOSE TO THE CONNECTING ROD, CREATING FRICTION AND CREATING THE BLACK POWDER. BASED ON THE INVESTIGATION, THE ISSUE DESCRIBED IN THIS COMPLAINT HAS ALREADY BEEN ADDRESSED IN SCAR 58 (WHICH AFFECTED BOTH 18070 &18080). THE CHANGES WERE IMPLEMENTED IN OCTOBER 2015. THE SERIAL NUMBER OF THE UNIT IN QUESTION (13S1507004734) PREDATES THESE CHANGES.

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTIFICATION OF AN INCIDENT FROM A PATIENT USING A NEBULIZER THAT (B)(4) IMPORTS AND DISTRIBUTES. THE END USER WAS USING THE NEBULIZER (18070) ALLEGEDLY WHEN THE MOTOR BECAME INCREASINGLY LOUDER AND STARTED VIBRATING. SHE POWERED THE NEBULIZER ON/OFF AND NO AIR FLOW WAS BEING PRODUCED. SHE WAS TAKEN TO (B)(6) HOSPITAL WHERE SHE STAYED FOR 2 DAYS. THE END USER STATED SHE IS FINE NOW BUT, WOULD LIKE A REPLACEMENT UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517489 DRIVE NEBULIZER CAF SHENZHEN HOMED MEDICAL DEVICE CO LTD 18070 00822383264851

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization