BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 4110816 · Received September 23, 2014

    Report

    Report Number
    8020893-2014-02229
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS COMPLETING THE REPAIR OF THE DEVICE AND IS WAITING FOR PARTS.(B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT THE DISPLAY ON AN 840 VENTILATOR WAS BLANK. THE CUSTOMER REPORTED THAT THE CABLE BETWEEN THE BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCB) AND THE LIQUID CRYSTAL DISPLAY (LCD) SEEMS DAMAGED FROM HEAT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589646 840 VENTILATOR CONTINUOUS VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1