BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODKNIGHT 420

    MDR report key: 2160313 · Received April 28, 2011

    Report

    Report Number
    3008361498-2011-00003
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 19, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    NNI
    PMA / PMN Number
    K050886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT STATING BLOWER DOESN'T BLOW. DURING INVESTIGATION IT WAS FOUND THAT THE INLET BAFFLE FOAM WAS DETERIORATING. NO PATIENT HARM REPORTED AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 420 CPAP MACHINE NNI NELLCOR PURITAN BENNETT GK420E

    Patients

    Seq Age Sex Outcome Treatment
    1