BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PB560 VENTILATOR

    MDR report key: 2255826 · Received August 22, 2011

    Report

    Report Number
    8020893-2011-00362
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    May 14, 2011
    Report Date
    July 27, 2011
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID (B)(6) IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K # FOR UNITED STATES DISTRIBUTED PART IS K082966.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING: "VENT SHUT DOWN ON PT WITH A SQUEAL." 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 VENTILATOR CBK COVIDIEN PB560

    Patients

    Seq Age Sex Outcome Treatment
    1