BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGI-FLO AUTOMATIC MANIFOLD

    MDR report key: 16960806 · Received May 19, 2023

    Report

    Report Number
    2020813-2023-00003
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 19, 2023
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830027747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY REPORTED THAT FOLLOWING THE PROCEDURE IT WAS IDENTIFIED THAT THE GAS LINES WERE SET UP INCORRECTLY BY THE THIRD-PARTY INSTALLER REVERSING THE OXYGEN AND NITROUS OXIDE GAS INPUT INTO THE UNIT. USER FACILITY PERSONNEL IMMEDIATELY REMOVED THE UNIT FROM SERVICE FOLLOWING THE REPORTED EVENT. THE USER FACILITY SHOULD HAVE ENSURED THEIR GAS LINES WERE PROPERLY INSTALLED PRIOR TO USE OF THE UNIT. THE USER FACILITY REPORTED THEY WERE UNAWARE OF THE REQUIREMENT TO HAVE THE GAS PIPING CERTIFIED BY MEDICAL GAS PLUMBERS AS STATED IN THE INSTRUCTIONS FOR USE. THE DIGI-FLO AUTOMATIC MANIFOLD USER MANUAL STATES (12), "NATIONAL FIRE PROTECTION ASSOCIATION STANDARD FOR HEALTH CARE FACILITIES ADDRESSES: BUILDING REQUIREMENTS BASED ON LEVELS OF SEDATION DELIVERY TO PATIENTS, FIRE, AND ELECTRICAL HAZARDS IN HEALTH CARE FACILITIES THROUGH PERFORMANCE, MAINTENANCE, TESTING AND SAFETY PRACTICES FOR BOTH THE FACILITIES AND THE MATERIAL, EQUIPMENT AND APPLIANCES THEY CONTAIN. THE INSTALLATION OF THE GAS STORAGE MUST BE IN ACCORDANCE WITH THE NATIONAL FIRE PROTECTION ASSOCIATION STANDARDS AND INSPECTED BY THE LOCAL 3RD PARTY VERIFIERS AND BUILDING DEPARTMENTS TO ASSURE COMPLIANCE WITH THE NFPA AND LOCAL CODES. THE INSTALLATION OF MEDICAL GAS PIPING MUST BE BY CERTIFIED MEDICAL GAS PLUMBERS." ADDITIONALLY, THE USER FACILITY SHOULD HAVE PERFORMED THE OXYGEN FAILSAFE / CROSSED LINE TEST PRIOR TO FIRST USE OF THEIR FLOWMETER. THE DIGITAL ULTRA FLOWMETER USER MANUAL STATES (24), "OXYGEN FAILSAFE / CROSSED LINE TEST CHECK PRIOR TO FIRST USE, WHEN METER IS MOVED, OR MONTHLY...SET FLOW TO 8 LPM TOTAL FLOW AND 50% N2O AND THEN SHUT OFF ALL OXYGEN CYLINDERS. UNIT SHOULD GO INTO OXYGEN FAILURE ALARM AND N2O FLOW SHOULD STOP. NOTE: THIS MAY TAKE A FEW MINUTES FOR LARGE CENTRAL SYSTEMS TO USE UP GAS IN O2 PASSAGES. IF GAS CONTINUES TO FLOW, N2O GAS MAY BE COMING IN ON OXYGEN LINES OR CIRCUIT BOARD COULD BE DAMAGED. DISCONTINUE USE IMMEDIATELY AND CONTACT CROSSTEX AS PATIENTS COULD SUFFER SEVERE INJURY." ACCUTRON COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE DIGI-FLO AUTOMATIC MANIFOLD SPECIFICALLY ON CERTIFYING THE INSTALLATION OF THE GAS PIPING PRIOR TO USE. THE USER FACILITY HAS MADE THE NECESSARY ADJUSTMENTS TO THE GAS LINES. THE USER FACILITY IS PENDING A CERTIFICATION BY A MEDICAL GAS PLUMBER PRIOR TO RETURNING TO THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE DIGI-FLO AUTOMATIC MANIFOLD, A PATIENT'S EYES ROLLED AND MUSCLE CONVULSION WAS OBSERVED. THE MASK WAS REMOVED FROM THE PATIENT AND THE PATIENT REGAINED CONSCIOUSNESS. THE PATIENT IS REPORTED TO BE FULLY RECOVERED AND THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074863 DIGI-FLO AUTOMATIC MANIFOLD MANIFOLD BSZ ACCUTRON, INC. 27497-FRU 00813830027747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown