BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2864518 · Received December 6, 2012

    Report

    Report Number
    8020893-2012-01370
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    June 9, 2012
    Report Date
    November 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO TRY TO OBTAIN FURTHER INFORMATION BUT NO RESPONSE RECEIVED FROM THE REPORTER.

    Description of Event or Problem · 1

    RECEIVED A MEDSUN REPORT ON (B)(4) 2012. REFERENCE NUMBER: (B)(4). THE REPORTED STATED THAT VENTILATOR STARTED ALARMING AND STATED TO ADJUST ALARM BY PRESSING DOWN BUTTON, THIS DID NOT WORK AND VENTILATOR INOPERABLE. PATIENT IMMEDIATELY TAKEN OFF VENTILATOR AND PLACED ON NEW VENTILATOR. NO PATIENT HARM. VENTILATOR TAKEN OUT OF SERVICE, SERVICED BY BIOMED DEPARTMENT AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1