BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 6740677 · Received July 25, 2017

    Report

    Report Number
    8020893-2017-07092
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Report Date
    April 25, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    UDI-DI
    10884521077133
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS IDENTIFIED ON 2018-APR-25 THAT THE DEVICE EVALUATION INFORMATION, PATIENT INVOLVEMENT, AND PMA/510K # NEEDED TO BE CORRECTED. PATIENT INVOLVEMENT WAS CORRECTED TO: THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. PMA / 510(K) # TO K151252. EVALUATION CODES UPDATED. DEVICE EVALUATION: EVALUATION SUMMARY: A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE OXYGEN SENSOR. THE UNIT PASSED TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 840 VENTILATOR'S OXYGEN SENSOR FAILED CALIBRATION. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520039 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840 10884521077133

    Patients

    Seq Age Sex Outcome Treatment
    1