BEUDAMED
    FDA Adverse Event Injury Summary report: N

    980 VENTILATOR

    MDR report key: 4153039 · Received October 8, 2014

    Report

    Report Number
    8020893-2014-02311
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K131252
    Removal / Correction Number
    Z-0180-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. A FIELD CORRECTIVE ACTION WAS INITIATED ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IDENTIFIED THAT THE CAUSE OF THE BLANK DISPLAY AND THE BURNING SMELL WAS THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (BLI PCB). IT WAS IDENTIFIED THAT ONE OF THE CAPACITORS WAS BLOWN AND CRACKED ON THE BLI PCBA. THE BLI PCBA CONTAINS A CERAMIC CAPACITOR THAT MAY HAVE EXPERIENCED MECHANICAL STRESSES DURING THE SUPPLIER PRODUCTION PROCESS. THESE STRESSES MAY CAUSE CRACKS IN THE CAPACITOR STRUCTURE AND THIS CAN LEAD TO LOW LEVEL CURRENT FLOW THROUGH THE CAPACITOR. THE CURRENT FLOW CAN CAUSE THE CAPACITOR TO BECOME DEFECTIVE AND POTENTIALLY EMIT A THERMAL ODOR. THE CAPACITOR WILL STOP FUNCTIONING AND CAN CAUSE DIMMING OF THE SCREEN; HOWEVER THE VENTILATOR REMAINS FULLY FUNCTIONAL. A FIELD ACTION TO CORRECT THIS ISSUE WAS IMPLEMENTED ON (B)(4) 2014.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE, THE 980 VENTILATOR TOUCH SCREEN BECAME HOT TO TOUCH AND HAD A BURNING SMELL. THE PATIENT WAS REMOVED FROM THE DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631781 980 VENTILATOR VENTILATOR, CONTINUOUS USE, FACILITY USE CBK COVIDIEN 980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention