BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREGUARD EASY AIR

    MDR report key: 1903574 · Received November 12, 2010

    Report

    Report Number
    1041130-2010-00010
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 24, 2010
    Report Date
    November 12, 2010
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEM, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. F/U ATTEMPTS WERE MADE, BUT STILL HAVE NOT RECEIVED PRODUCT. THIS PROBLEM WAS IDENTIFIED IN HOUSE ON (B)(4) 2009 AND A CAR WAS ISSUED TO OUR MFR ON THAT DATE. WE DID SORT INTERNALLY FOR THIS SYMPTOM DURING THAT TIME. ROOT CAUSE WAS IDENTIFIED AND CORRECTIVE ACTION WERE TAKEN ON (B)(4) 2009. THE SPACER FABRIC MATERIAL DIAMETER WAS TOO LARGE AND INTERFERING WITH THE WELDING PROCESS, CAUSING POOR WELDS. THIS IS A "SPOT" PROBLEM AND NOT A CATASTROPHIC ENTIRE COVER TOP ISSUE. THIS PARTICULAR COVER WAS PART OF THE PRODUCTION RUN PRIOR TO TAKING CORRECTIVE ACTION.

    Description of Event or Problem · 1

    WE RECEIVED A PHONE CALL STATING THAT THEY HAD 2 WELD FAILURES ON A PRESSUREGUARD EASY AIR COVER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1