BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 15614750 · Received October 17, 2022

    Report

    Report Number
    1314417-2022-00020
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 20, 2022
    Report Date
    October 17, 2022
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    UDI-DI
    10889483103012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    A DUCKBILL NOT OPENING DURING CODE WOULD LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET SUMMARY: RETURNED PRODUCT CONFIRMED THE COMPLAINT. DURING INVESTIGATION OF THE DEVICE WITHOUT A MANUFACTURING DATE/LOT NUMBER, IT WAS FOUND THAT THE DEVICE WAS MADE PRIOR TO CERTAIN ENGINEERING CHANGES DATING TO 2015. RA: RMA-20020 CONTAINS APPROPRIATE RISK ASSESSMENT. PREVIOUS CORRECTIVE ACTIONS OF CAPA14-016 AND MI-CO19-0225 ADDRESS THE NON-CONFORMANCE IDENTIFIED BY THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    A DUCKBILL NOT OPENING DURING CODE WOULD LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET

    Description of Event or Problem · 0

    THE DUCKBILLED VALVE WOULDN'T OPEN DURING A CODE.

    Description of Event or Problem · 0

    THE DUCKBILLED VALVE WOULDN'T OPEN DURING A CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312573 SUNMED HOLDINGS LLC SMALL ADULT AIRFLOW W/MANOMETER BTM SUNMED HOLDINGS LLC AF5140MB 10889483103012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other