BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PB560 VENTILATOR X1

    MDR report key: 2092845 · Received April 20, 2011

    Report

    Report Number
    8020893-2011-00175
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(4) IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K # FOR US DISTRIBUTED PART IS K082966.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFO STATING, THAT THE UNIT STOPPED WORKING DURING BREATHING WITHOUT GIVING ALARM. THE PT AWOKE AND SAW "CONTROLED CYCLES" AT THE UNIT WITH VERY LOW FLOW. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PB560 VENTILATOR X1 VENTILATOR CBK NELLCOR PURITAN BENNETT 560

    Patients

    Seq Age Sex Outcome Treatment
    1