BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3940181 · Received March 21, 2014

    Report

    Report Number
    8020893-2014-00675
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S TECHNICAL SERVICE ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. IT WAS RECOMMENDED THAT THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) BE REPLACED. THE USER FACILITY HAS NOT CONTACTED THE MANUFACTURED FOR SERVICE OR REPAIR. SHOULD THE USER FACILITY REQUEST REPAIR OR PROVIDE ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SERVICE HISTORY RECORD FOR THIS DEVICE 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. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATING THE DEVICE EXPERIENCED ERROR CODES XP0087 (UNEXPECTED RESET UMPIRE TEST) AND UT0002 (BUS ERROR / ACCESS FAULT) WHILE ON PT. THE PT WAS REMOVED FROM THE DEVICE AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168325 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention