BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED LLC

    MDR report key: 17795871 · Received September 21, 2023

    Report

    Report Number
    1314417-2023-00020
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 20, 2023
    Report Date
    September 21, 2023
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    UDI-DI
    10889483103012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE AIR LEAKING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED. THE COMPLAINT OF "AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2." REGARDING PART NUMBER AF5140MB/LOT 428861 WAS CONFIRMED. RETURNED PRODUCT WAS INVESTIGATED. VISUAL INSPECTION IDENTIFIED A LOOSE DIAPHRAGM VALVE WITHIN THE BAG BODY AND IT WAS CONCLUDED THAT THE DIAPHRAGM VALVE WAS NOT ASSEMBLED CORRECTLY AND BECAME LOOSE PRIOR TO END-USE. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE HIGH WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD; THE COMPLAINT WAS SUBMITTED TO CARB AND THEY DECIDED TO OPEN A CAPA (CAPA-00513) FOR THIS ISSUE. THERE HAVE BEEN TWO (2) OTHER CONFIRMED COMPLAINTS REGARDING PART NUMBER AF5140MB FOR THE SAME ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A MEMO, CONTAINING THE COMPLAINT INVESTIGATION, WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    THE AIR LEAKING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED.

    Description of Event or Problem · 0

    AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2.  OCCURRED DURING PATIENT USE, POSSIBLE DELAY IN TREATMENT.

    Description of Event or Problem · 0

    AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2.  OCCURRED DURING PATIENT USE, POSSIBLE DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524916 SUNMED LLC SMALL ADULT AIRFLOW W/MANOMETER BTM SUNMED HOLDINGS LLC AF5140MB 428861 10889483103012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other