BEUDAMED
    FDA Adverse Event Death Summary report: N

    DBD-ADAPTER,LVN,BLUE,33%-98%,ADAPT ONLY,

    MDR report key: 23526218 · Received November 11, 2025

    Report

    Report Number
    1417592-2025-00620
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    October 3, 2025
    Report Date
    June 10, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, "THE ADAPTOR HAD DISCONNECTED FROM THE TOP SCREW ON CONNECTION AND THE AIR WAS LEAKING FROM THE DISCONNECTED PART JUST ABOVE THE CONCENTRATION SELECTOR AND PATIENT WAS NOT RECEIVING ANY OXYGEN WHICH HAD CAUSED THE MONITOR TO ALARM AND ALERT STAFF." NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED H6: TYPE OF INVESTIGATION (B). UPDATED H6: INVESTIGATION FINDINGS (C).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE ADAPTOR BECAME "DISCONNECTED FROM THE WATER BOTTLE AND FELL TO THE FLOOR, CAUSING STAFF TO OBTAIN ANOTHER SYSTEM". THE CUSTOMER REPORTED AS A RESULT THE "PATIENT DID PASS AWAY", BUT THEY DID NOT WANT TO STATE THAT THE PRODUCT WAS THE CAUSE DUE TO THE PATIENT DOING "POORLY". DESPITE THE CUSTOMER REPORT, THE PRODUCT ISSUE WAS FOLLOWED WITH A PATIENT DEATH, THEREFORE THE INCIDENT WILL BE CONSIDERED A CONTRIBUTING FACTOR TO THE PATIENT DEATH. UPDATED: B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT. B5: DESCRIBE EVENT OF PROBLEM. H1: TYPE OF REPORTABLE EVENT. H6: HEALTH EFFECT - IMPACT CODE (F).

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, "THE ADAPTOR HAD DISCONNECTED FROM THE TOP SCREW ON CONNECTION AND THE AIR WAS LEAKING FROM THE DISCONNECTED PART JUST ABOVE THE CONCENTRATION SELECTOR AND PATIENT WAS NOT RECEIVING ANY OXYGEN WHICH HAD CAUSED THE MONITOR TO ALARM AND ALERT STAFF."

    Description of Event or Problem · 0

    THE ADAPTOR BECAME "DISCONNECTED FROM THE WATER BOTTLE AND FELL TO THE FLOOR, CAUSING STAFF TO OBTAIN ANOTHER SYSTEM". THE CUSTOMER REPORTED AS A RESULT THE "PATIENT DID PASS AWAY", BUT THEY DID NOT WANT TO STATE THAT THE PRODUCT WAS THE CAUSE DUE TO THE PATIENT DOING "POORLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502468 DBD-ADAPTER,LVN,BLUE,33%-98%,ADAPT ONLY, CAF MEDLINE INDUSTRIES, LP 74K2200910

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O