BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM VENTILATOR

    MDR report key: 6884989 · Received September 21, 2017

    Report

    Report Number
    2020676-2017-00022
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 28, 2017
    Report Date
    August 28, 2017
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K993167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SECHRIST TECHNICAL SERVICE MANAGER DETERMINED THE FAILURE TO BE WITH THE COMPONENT 21437 - BACK PLATE, ASSY NOT BEING CALIBRATED AND SHIPPED CUSTOMER A NEW, CALIBRATED BACK PLATE, ASSY TO INSTALL ON THEIR MILLENNIUM VENTILATOR AND PROVIDED THE CUSTOMER WITH A RETURN MATERIAL AUTHORIZATION (RMA) TO RETURN THE BACK PLATE, ASSY BUT IT HAS NOT BEEN RECEIVED. CUSTOMER IS LOCATED IN THE (B)(6). THIS FAILURE MODE IS MITIGATED THROUGH LABELING AND/OR INSTRUCTIONS IN THE MANUAL THAT WOULD ALLOW THE USER TO DETECT THE PROBLEM AND PRECLUDE THE DEVICE FROM USE. PRIOR TO EACH CLINICAL USE IT IS RECOMMENDED THAT THE DEVICE RECEIVE PERFORMANCE VERIFICATION. THIS REPORT WAS SUBMITTED TO THE FDA TO COMPLY WITH MDR MALFUNCTION NOTICE 76 FR 12743 REQUIRING THE REPORTING OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. MILLENNIUM VENTILATOR PN'S 23065-1/ 20409-1 SERIAL (B)(4) WAS MANUFACTURED ON 06/01/2005. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER ORDERED AND RECEIVED THE BACK PLATE ASSEMBLY AND INSTALLED IT ONTO THE MILLENNIUM VENTILATOR. HOWEVER, WHEN THEY TURNED ON THE UNIT AN ERROR MESSAGE E03: CM EEPROM FAIL CAME UP. THIS WAS DISCOVERED DURING REGULARLY SCHEDULED TESTING, NO PATIENT INVOLVEMENT OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663964 MILLENNIUM VENTILATOR VENT,MILLENNIUM,ENGLISH CBK SECHRIST INDUSTRIES, INC. 20409-1

    Patients

    Seq Age Sex Outcome Treatment
    1