BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREGUARD EASY AIR

    MDR report key: 1821400 · Received August 27, 2010

    Report

    Report Number
    1041130-2010-00007
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 27, 2010
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEM, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE FAILURE IS REPORTED AS A RESULT OF A PREVIOUS, SIMILAR FAILURE ASSOCIATED WITH A PT FALLING OFF THE MATTRESS. THIS DESIGN WAS DISCONTINUED IN (B)(4) 2006.

    Description of Event or Problem · 1

    THIS IS A REPEAT PRODUCT DEFECT OCCURRENCE FOR PREVIOUS MDR 1041130-2007-00001 WITH A REPORT DATE OF (B)(6) 2007, PRESSUREGUARD EASY AIR, AN ALTERNATING PRESSURE MATTRESS, FOR A WELD FAILURE IN THE TOP COVER FABRIC. THIS EVENT DID NOT RESULT IN AN ADVERSE EVENT FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREGUARD EASY AIR ALTERNATING PRESSURE MATTRESS FNM SPAN-AMERICA MEDICAL SYSTEM, INC. LM8035-29 NA

    Patients

    Seq Age Sex Outcome Treatment
    1