BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTEC

    MDR report key: 8333247 · Received February 12, 2019

    Report

    Report Number
    1832475-2019-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    June 6, 2009
    Report Date
    February 12, 2019
    Manufacturer
    FLOTEC INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO LACK OF CONTACT INFORMATION, WE WERE UNABLE TO CONTACT THE REPORTING INDIVIDUAL TO OBTAIN THE UNIT IN QUESTION FOR INVESTIGATION. WE WOULD LIKE TO NOTE THAT THE INGAGE REGULATOR IS NOT INTENDED AS A LIFE-SUSTAINING DEVICE. WE CONDUCTED AN INVESTIGATION ON THE MANUFACTURING OF OUR INGAGE REGULATORS. THE GAUGE FUNCTIONS BY A MOVING MEASURING DEVICE ATTACHED TO AN OUTER DECAL RING WHICH DISPLAYS THE PRESSURE MEASUREMENT. AT THE TIME OF THE REPORTED INCIDENT, OUR MANUFACTURING PROCESS RELIED ON A PURELY MECHANICAL CONNECTION BETWEEN THE MEASURING DEVICE AND THE DECAL. THERE EXISTED THE POTENTIAL FOR THE DECAL TO BECOME DISCONNECTED FROM THE MEASURING DEVICE. IF THIS OCCURS, THE DISPLAY WOULD NOT CHANGE IN RESPONSE TO PRESSURE CHANGES, AND THE REPORTED DEVICE MALFUNCTION COULD OCCUR. IN OUR CURRENT MANUFACTURING PROCESS, THE DECAL IS ATTACHED TO THE MEASURING DEVICE BY A MECHANICAL CONNECTION AS WELL AS AN ADHESIVE. THIS ADDITIONAL STEP IN OUR MANUFACTURING PROCESS GREATLY REDUCES THE RISK OF THE DECAL DETACHING FROM THE MEASURING DEVICE AND CAUSING A FAILURE MODE SIMILAR TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT IS OUR RESPONSE TO REPORT NUMBER MW5012641 WITH MDR REPORT KEY (B)(4). THAT REPORT WAS ISSUED ON 08/27/2009. DUE TO LACK OF CONTACT INFORMATION, WE WERE UNABLE TO CONTACT THE REPORTING INDIVIDUAL TO OBTAIN THE UNIT IN QUESTION FOR INVESTIGATION. WE WOULD LIKE TO NOTE THAT THE INGAGE REGULATOR IS NOT INTENDED AS A LIFE-SUSTAINING DEVICE. WE CONDUCTED AN INVESTIGATION ON THE MANUFACTURING OF OUR INGAGE REGULATORS. THE GAUGE FUNCTIONS BY A MOVING MEASURING DEVICE ATTACHED TO AN OUTER DECAL RING WHICH DISPLAYS THE PRESSURE MEASUREMENT. AT THE TIME OF THE REPORTED INCIDENT, OUR MANUFACTURING PROCESS RELIED ON A PURELY MECHANICAL CONNECTION BETWEEN THE MEASURING DEVICE AND THE DECAL. THERE EXISTED THE POTENTIAL FOR THE DECAL TO BECOME DISCONNECTED FROM THE MEASURING DEVICE. IF THIS OCCURS, THE DISPLAY WOULD NOT CHANGE IN RESPONSE TO PRESSURE CHANGES, AND THE REPORTED DEVICE MALFUNCTION COULD OCCUR. IN OUR CURRENT MANUFACTURING PROCESS, THE DECAL IS ATTACHED TO THE MEASURING DEVICE BY A MECHANICAL CONNECTION AS WELL AS AN ADHESIVE. THIS ADDITIONAL STEP IN OUR MANUFACTURING PROCESS GREATLY REDUCES THE RISK OF THE DECAL DETACHING FROM THE MEASURING DEVICE AND CAUSING A FAILURE MODE SIMILAR TO THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123237 FLOTEC INGAGE REGULATOR CAN FLOTEC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention