BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 6758880 · Received August 1, 2017

    Report

    Report Number
    8020893-2017-07247
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    July 5, 2017
    Report Date
    April 26, 2018
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K151252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED ON 2018-APR-25 REGARDING THE DEVICE EVALUATION. (B)(4). CORRECTION: CATALOG NUMBER CORRECTED TO 4-840120DIJJ-JP, PMA / 510(K) # CORRECTED TO K151252. EVALUATION SUMMARY: A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE UNIT PASSED TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. THE DEVICE HAS BEEN RETURNED TO USE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    COVIDIEN/MEDTRONIC HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, AN 840 VENTILATOR'S LOWER DISPLAY BLACKED OUT. IT WAS REPORTED THAT AFTER REBOOTING THE VENTILATOR, THE CONDITION DID NOT APPEAR. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537199 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention