BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREGUARD EASY AIR

    MDR report key: 2240614 · Received April 12, 2007

    Report

    Report Number
    1041130-2007-00004
    Event Type
    Malfunction
    Date Received
    April 12, 2007
    Date of Event
    March 23, 2007
    Report Date
    April 12, 2007
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEM, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: SERIAL #: (B)(4). THIS DEVICE FAILURE IS REPORTED AS A RESULT OF A PREVIOUS, SIMILAR FAILURE ASSOCIATED WITH A PT FALLING OFF THE MATTRESS. WE HAVE RECEIVED 75 COMPLAINTS OF WELD FAILURES IN THE TOP COVER OF THIS DESIGN, WITH ONE FAILURE ASSOCIATED WITH PT INJURY. THIS DESIGN WAS DISCONTINUED IN (B)(6) 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 WELD FAILURE IN THE TOP COVER FABRIC. THIS CUSTOMER COMPLAINT IS FOR FAILURE FOR THREE MATTRESSES. THESE EVENTS 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. 8000B

    Patients

    Seq Age Sex Outcome Treatment
    1