BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3870085 · Received April 28, 2014

    Report

    Report Number
    8020893-2014-01006
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    GALWAY (R) -RX
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECHNICAL SERVICE ADVISED THE CUSTOMER TO TRY TO DO GROUND ISOLATION AND A VENTILATOR INOPERATIVE TEST AND RUN THE UNIT A DAY OR 2 TO TRY TO DUPLICATE THE ISSUE. COVIDIEN REF.: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT AN 840 VENTILATOR HAD VENTILATOR INOPERATIVE ERROR CODE. THERE WAS NO PT INVOLVEMENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254523 840 VENTILATOR CBK GALWAY (R) -RX 840

    Patients

    Seq Age Sex Outcome Treatment
    1