BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEP SUPPORT SYSTEM

    MDR report key: 731242 · Received June 30, 2006

    Report

    Report Number
    2529571-2006-00001
    Event Type
    Other
    Date Received
    June 30, 2006
    Date of Event
    March 7, 2006
    Report Date
    June 30, 2006
    Manufacturer
    NA
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SLEEP SUPPORT MANUAL SHOWS THE CORRECT SET-UP OF THE DEVICE. THERE IS NO CLEAR CAUTION THAT THE DEVICE SHOULD NOT BE SET-UP 180 OPPOSITE PICTURE IN MANUAL (SEE ATTACHMENT C). IF THE PT SET-UP THE DEVICE INCORRECTLY, THIS IS THE ONLY WAY TO HIT THE VELCRO IN THE NECK AREA.

    Description of Event or Problem · 1

    PT LEFT MESSAGE ON 03/07/2006 AT 5PM THAT HE WAS IN THE HOSP OVER THE WEEKEND BECAUSE OUR SLEEP SYSTEM COLLAPSED, HE INJURED HIS THROAT. I CALLED WILLIAM THIS MORNING AND HE SAID THE BAR COVERED BY VELCRO DUG INTO HIS THROAT WHEN UNIT COLLAPSED. HE DID NOT WANT TO GIVE ME ANYMORE INFO AFTER I REMARKED THAT HE MAY HAVE HAD IT SET UP WRONG. WILLIAM SAID HE JUST WANTED TO GET THE UNIT OUT OF HIS HOUSE. LINDA, LET ME KNOW IF YOU SEE ANYTHING ODD WHEN THIS UNIT COMES BACK OR LET ME KNOW IF YOU NEED ME TO LOOK AT IT. THANKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEP SUPPORT SYSTEM FACE SUPPORT CCX NA 3009 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization