BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3831905 · Received March 6, 2014

    Report

    Report Number
    8020893-2014-00562
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 2, 2014
    Report Date
    February 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SERVICE ENGINEER (CSE) REPORTED THE BREATHING DELIVERY UNIT CENTRAL PROCESSING UNIT (BDU CPU) WAS REPLACED AND WAS RETURNED TO THE MANUFACTURING SITE. THE SERVICE HISTORY RECORD (SHR) WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. UPON COMPLETION OF INVESTIGATION AND EVAL, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) INDICATES THE DEVICE EXPERIENCED A SAFETY VALVE OPEN (SVO) CODE WHEN THE DEVICE WAS TURNED ON PRIOR TO PT USE. THERE WAS NO PT INVOLVEMENT NOTED. CUSTOMER STATES PRIOR TO USE, SVO OCCURRED WHEN THE DEVICE WAS STARTED UP. ADDITIONALLY, THE DEVICE DISPLAYED KP0012 (TIMER TEST) WHICH WOULD RENDER THE DEVICE INOPERABLE. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135931 840 VENTILATOR CBK VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1