BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3964621 · Received May 30, 2014

    Report

    Report Number
    8020893-2014-01314
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COVIDIEN, FORMELRY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE BIOMEDICAL TECHNICIAN TROUBLESHOT THE 840 VENTILATOR FOUND A LOOSE OXYGEN SENSOR, WHICH WAS TIGHTENED, EXTENDED SELF-TESTING WAS PERFORMED ON THE DEVICE, AND ALL TESTS WERE SUCCESSFUL. THE CUSTOMER CANCELED THE COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) REPAIR CALL, AND CSE WAS UNABLE TO VISUALLY EVALUATE THE UNIT. ADDITIONALLY, THE CUSTOMER INFORMED THAT THE UNIT WAS FUNCTIONING WITHIN MANUFACTURER'S SPECIFICATIONS, AND NO OTHER INFORMATION WAS PROVIDED. COVIDIEN REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING TESTING, THE 840 VENTILATOR WAS FOUND TO HAVE FAILED THE SAFETY VALVE (SV) PRESSURE TEST, RESULTING IN THE VENT ENTERING INTO A DEVICE INOPERATIVE MODE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320100 840 VENTILATOR CBK COVIDIEN, FORMELRY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1