BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 15827984 · Received November 18, 2022

    Report

    Report Number
    1314417-2022-00021
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    September 11, 2022
    Report Date
    November 18, 2022
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    UDI-DI
    10889483103012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS NOT ABLE TO PROVIDE RESPIRATORY SUPPORT TO THE PATIENT. THE BVM MALFUNCTIONING WOULD POTENTIALLY 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

    REPORTABLE AS NOT ABLE TO PROVIDE RESPIRATORY SUPPORT TO THE PATIENT. THE BVM MALFUNCTIONING WOULD POTENTIALLY 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

    BVM MALFUNCTIONED AND PATIENT WAS NOT ABLE TO BE VENTILATED FOR AN UNKNOWN REASON.

    Description of Event or Problem · 0

    BVM MALFUNCTIONED AND PATIENT WAS NOT ABLE TO BE VENTILATED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229074 SUNMED HOLDINGS LLC SMALL ADULT AIRFLOW W/MANOMETER BTM SUNMED HOLDINGS LLC AF5140MB UNKNOWN 10889483103012

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other