BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 6653669 · Received June 20, 2017

    Report

    Report Number
    8020893-2017-06652
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    May 28, 2017
    Report Date
    April 18, 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

    CORRECTION: PMA/510 K NUMBER CORRECTED TO K151252. (B)(4). MODEL NUMBER CORRECTED TO 4-840120DIJJ-JP ADDITIONAL INFORMATION: ADDED UNIQUE IDENTIFIER (UDI) # ADDITIONAL INFORMATION WAS RECEIVED ON 2017-08-24, PROVIDING THE VENTILATOR REPAIRS. DEVICE EVALUATION: A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE IN USE ON A PATIENT, THE VENTILATOR GENERATED AN ALARM AND THE DEVICE STOPPED VENTILATING THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE DEVICE HAS NOT BEEN EVALUATED AS OF THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434229 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 4-840120DIJJ-JP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention