BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEMBRANE CHANGER (RELOADABLE) / SINGLE UNIT

    MDR report key: 18029688 · Received October 30, 2023

    Report

    Report Number
    18029688
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    July 25, 2023
    Report Date
    September 12, 2023
    Manufacturer
    SENTEC AG
    Product Code
    LKD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SENTEC AG INITIATED A CUSTOMER INFORMATION LETTER FOR MEMBRANE CHANGER PRODUCTS DUE TO SPECIFIC LOTS POSSIBLY CONTAINING A NON-CONFORMING DEFECT. DURING THE MANUFACTURING PROCESS THERE WERE COMPONENTS THAT REQUIRED REWORK AND DURING THAT STEP, BUT BEFORE ASSEMBLY, AN ADDITIONAL PIECE OF MATERIAL MAY HAVE BEEN LEFT IN THE DEVICE. PLEASE NOTE WE NEVER ACTUALLY RECEIVED THIS NOTICE FROM SENTEC AG. WE DISCOVERED THE CUSTOMER INFORMATION LETTER THROUGH ECRI. THE POTENTIAL FOR HARM IS BASED ON THE LETTER FROM SENTEC AG STATING THE DEFECT COULD HAVE AN IMPACT ON MEASUREMENT READINGS, IMPACT ON THE SENSOR MEMBRANE AND POTENTIAL HARM TO PATIENT SKIN. BASED ON THIS INFORMATION, WE REQUESTED REPLACEMENT PRODUCTS FROM SENTEC AG. SENTEC AG DECLINED REPLACEMENT AND TOLD US THE DEFECT POSED NO IMPACT ON SKIN INTEGRITY. THIS RESPONSE DIFFERS FROM THE ALERT LETTER STATING IT AS A POTENTIAL FOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130604 MEMBRANE CHANGER (RELOADABLE) / SINGLE UNIT MONITOR, CARBON-DIOXIDE, CUTANEOUS LKD SENTEC AG MC-R 225253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown