BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 23658840 · Received November 26, 2025

    Report

    Report Number
    3009096682-2025-00013
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 26, 2025
    Manufacturer
    DEVILBISS HEALTHCARE, LLC
    Product Code
    BZD
    PMA / PMN Number
    K071689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THIS DEVICE WAS PLACED INTO COMMERCIAL DISTRIBUTION BACK IN MARCH 2012, WHICH PREDATES THE REQUIRED UDI COMPLIANCE DATE FOR CLASS II MEDICAL DEVICES. AS A RESULT, NO UDI# EXISTS FOR THIS DEVICE AND SECTION D4, PRIMARY UDI NUMBER, SHALL STATE NONE. REACT HEALTH ADVISED THE PATIENT THAT THE DEVICE HAS BEEN DISCONTINUED. AS A RESULT, THERE ARE NO LONGER ANY OPTIONS FOR REPLACEMENT OR REPAIR. THE DEVICE WILL NOT BE RETURNED TO REACT HEALTH FOR AN EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 3B MEDICAL, INC. DBA REACT HEALTH BY A PATIENT (VIA EMAIL) THAT THE BLACK SPONGE INSIDE OF THEIR DEVILBISS DV54 WAS "DAMAGED.¿ THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, NO PATIENT HARM OR INJURY WAS REPORTED. REACT HEALTH REQUESTED ADDITIONAL INFORMATION ABOUT THE "DAMAGED" BLACK SPONGE (INCLUDING PHOTOS) AND ASKED IF THE SPONGE WAS COMING OUT, AS WELL AS WHETHER THE DEVICE HAD BEEN DISASSEMBLED. THE PATIENT RESPONDED, ADVISING THAT ¿SMALL PARTICLES USED TO COME OUT BUT SETTLED IN A SHORT TIME.¿ AFTER THE DEVICE¿S BLOWER STOPPED WORKING, HE [PATIENT] HAD THE DEVICE ¿DISMANTLED¿ BY A LOCAL BIOMEDICAL TECHNICIAN WHO OBSERVED THAT THE BLACK COLORED SPONGE HAD DETERIORATED. THE DEVICE WAS THEN REASSEMBLED BY THE BIOMEDICAL TECHNICIAN. AS A RESULT, PHOTOGRAPHS OF THE DAMAGED SPONGE COULD NOT BE PROVIDED. [PLEASE NOTE: THE EVENT WAS REPORTED DIRECTLY TO REACT HEALTH BY THE PATIENT. AS A RESULT, SECTION E1 FIRST AND LAST NAME, AS WELL AS ADDRESS 1, SHALL BE LEFT BLANK AS IT IS PROTECTED HEALTH INFORMATION (PHI)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948576 DEVILBISS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD DEVILBISS HEALTHCARE, LLC DV54D-HH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown