BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERBARIC VENTILATOR

    MDR report key: 6150112 · Received December 6, 2016

    Report

    Report Number
    2020676-2016-00016
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS RETURNED FOR EVALUATION. THE UNIT WAS TESTED PER DOCUMENTS 170196 REV. 8AND 150094 REV. 7, THE UNIT WAS CHECKED FOR THE WATER TRAP WAS INSTALLED INLET AND OUTLET SWAP BACKWARDS. THE MASTER VALVE KNOB IS TILTED ABOUT 4 DEGREES AND THE MASTER VALVE IS LEAKING AT THE OUTLET. MAXIMUM INHALATION AND EXHALATION TIME ARE OUT OF SPECIFICATION. THE WINK LIGHT IS SLANTED. THE FILTER 3529E IS NATURALLY BROWN, THIS IS FROM THE BINDER FOR THE FILTER ELEMENT. ROOT CAUSE: ITEM 1 THE UNIT HAS SUFFERED HANDLING DAMAGE, ITEM 2 THE SLANTED WINK LIGHT WAS MISSED DURING ASSEMBLY AND INSPECTION, ITEMS 3 AND 4 THE UNIT WAS FOUND TO BE CLOSE THE MINIMUM SPECIFICATION DURING DHR REVIEW AND HAS DRIFTED OUT OF SPECIFICATION, ITEM 5 THE HOSE HAS DEVELOPED A LEAK, THIS MAY BE DUE TO A NICK IN THE TUBING AND THE HOSE CLAMP, ITEM 6 THE DIRECTION OF THE FLOW ARROW WAS MISSED BY PRODUCTION AND INSPECTION, IT SHOULD BE NOTED THAT THIS CONDITION MAY HAVE PREEXISTED BEFORE THE OVERHAUL AS THE WATER TRAP IS NEVER TAKEN OFF THE UNIT. THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE 76 FR 12473 REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING RECEIPT OF THERE VENTILATOR AFTER AN OVERHAUL, IT WAS NOTICED THAT THE FLOW ARROW ON THE FILTER WAS POINTING IN THE WRONG DIRECTION AND WAS BROWN. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799545 HYPERBARIC VENTILATOR VENTILATOR, CONTINUOUS CBK SECHRIST INDUSTRIES, INC. HV-500A

    Patients

    Seq Age Sex Outcome Treatment
    1