BEUDAMED
    FDA Adverse Event Death Summary report: N

    GOODKNIGHT 425

    MDR report key: 1039583 · Received May 7, 2008

    Report

    Report Number
    9615679-2008-00006
    Event Type
    Death
    Date Received
    May 7, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MALLINCKRODT DEVELOPPEMENT FRANCE
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD END-STAGE COPD, NOT SLEEP APNEA. AS PER HOSPICE "PATIENT INSISTED IN USING DEVICE 24/7, PATIENT WAS CLINGING TO THE MACHINE TO SURVIVE". PATIENT ONLY CAME OFF THE DEVICE BY LIFTING THE MASK TO EAT. HOSPICE HAS BEEN INFORMED THAT THE UNIT IS NOT LABELED FOR LIFE SUPPORT. THE DEVICE WAS INSPECTED AND TESTED BY THE DME, UNIT TESTED ACCORDING TO DME'S SPECS. NOR HOSPICE OR DME BELIEVE THE UNIT CONTRIBUTED TO PATIENT'S DEATH. UNIT IS NOW BEING UTILIZED ON A NEW PATIENT.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED INFORMATION SUGGESTING THAT A COPD PATIENT WAS ALLEGING SHE WAS SUFFOCATING WHILE USING A 425 GOODKNIGHT CPAP UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 425 GOODKNIGHT 425 BZD MALLINCKRODT DEVELOPPEMENT FRANCE GK425

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other