BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 7005232 · Received November 6, 2017

    Report

    Report Number
    2936999-2017-05607
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    August 23, 2017
    Report Date
    February 20, 2018
    Manufacturer
    MALLINCKRODT DAR SRL
    Product Code
    CBK
    UDI-DI
    10884521100251
    PMA / PMN Number
    K082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE WAS CONFIRMED. THE REPORTED CUSTOMER EVENT IS A KNOWN ISSUE AND ROOT CAUSE INVESTIGATION EFFORTS HAVE BEEN ADDRESSED IN A CORRECTIVE AND PREVENTATIVE ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TAB/FLAP APPEARED TO HAVE BEEN BROKEN OFF ON E-VALVE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY OR ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783677 DAR VENTILATOR, CONTINUOUS, FACILITY USE CBK MALLINCKRODT DAR SRL 111P1160 140701330X 10884521100251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention