BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-MED DEVICES, INC.

    MDR report key: 25134956 · Received May 11, 2026

    Report

    Report Number
    25134956
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    February 12, 2024
    Report Date
    April 28, 2026
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: TRANSPORT VENTILATOR MANAGEMENT AND TROUBLESHOOTING PROBLEM RESULTING IN PATIENT DESATURATION AND BRADYCARDIA. BACKGROUND: NICU [NEONATAL INTENSIVE CARE UNIT] TRANSPORT TEAM PICKING UP INTUBATED PATIENT FROM [REDACTED] NICU. THIS RN HAD TRANSFERRED AND STRAPPED PATIENT INTO TRANSPORT ISOLETTE, PLACED ON TRANSPORT VENTILATOR WITHOUT ISSUE WITH AIR/OXYGEN CONNECTED TO WALL. PREPARED TO DEPART FROM [REDACTED] NICU. ASSESSMENT: RT [RESPIRATORY THERAPIST] [REDACTED] DISCONNECTED FROM WALL AIR/OXYGEN, TRANSPORT VENTILATOR BEGAN ALARMING. RT SILENCED TRANSPORT VENTILATOR. WHEN THIS RN ASKED "WHAT'S BEEPING" RT WAS UNSURE/BEGAN TROUBLESHOOTING. THIS RN NOTED TRANSPORT VENTILATOR WAS NOT DELIVERING PEEP [POSITIVE END-EXPIRATORY PRESSURE] OR PIP [PEAK INSPIRATORY PRESSURE] AND VERBALIZED CONCERN. PATIENT WITH DESATURATION AND BRADYCARDIA. TRANSPORT RT WITH DIFFICULTY TROUBLESHOOTING AND RECOGNITION/ASSISTING IN ESTABLISHING ALTERNATIVE METHOD OF VENTILATION. TRANSPORT RN AND TRANSPORT PA [PHYSICIAN ASSISTANT] ATTEMPTED TO MANUALLY VENTILATE WITH [REDACTED] T-PIECE, BUT UNABLE TO ESTABLISH FLOW, ULTIMATELY PLACED BACK ON [REDACTED] DRAEGER VENTILATOR, WITH HELP FROM [REDACTED] RT. PATIENT RECOVERED (30-45 SECONDS). DETERMINED TRANSPORT VENTILATOR HAD NOT BEEN CONNECTED APPROPRIATELY BY TRANSPORT RT TO STRYKER/TANK FLOW. TRANSPORT VENTILATOR RECHECKED BY TRANSPORT RT AND PATIENT ABLE TO BE PLACED ON TRANSPORT VENTILATOR CORRECTLY. RECOMMENDATION/REQUEST: GIVEN CONCERN FOR KNOWLEDGE GAP AND CRITICAL THINKING/PROBLEM SOLVING, RE-EDUCATION. CONCERNED ABOUT THIS RT SERVING AS PEDIATRIC TRANSPORT RT FOR PATIENTS REQUIRING RESPIRATORY SUPPORT. MANUFACTURER RESPONSE FOR TRANSPORT VENTILATOR, TV100 (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577304 BIO-MED DEVICES, INC. VENTILATOR, CONTINUOUS, FACILITY USE CBK BIO-MED DEVICES, INC. TV-100

    Patients

    Seq Age Sex Outcome Treatment
    1