BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESSUREGUARD EASY AIR

    MDR report key: 745069 · Received August 3, 2006

    Report

    Report Number
    1041130-2006-00001
    Event Type
    Other
    Date Received
    August 3, 2006
    Date of Event
    June 15, 2006
    Report Date
    July 30, 2006
    Manufacturer
    SPAN-AMERICA MEDICAL SYSTEMS, INC.
    Product Code
    FNM
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SPAN-AMERICA REC'D THE CALL FROM REP , FDA ON 6-30-06 REPORTING THAT MDR WAS REC'D REPORTING A FIRE ASSOCIATED WITH THE PRESSUREGUARD EASY AIR. SPAN REC'D A COPY OF THE REPORT FROM THE USER FACILITY ON 7-7-06. IN PHONE DISCUSSIONS WITH THE FACILITY, THE PRODUCT WOULD BE RETURNED FOLLOWING COMPLETION OF THEIR INVESTIGATION. WE WERE THEN INFORMED OF THE DECISION BY THE FACILITY TO NOT RETURN THE UNIT TO SPAN. THE FIRE CAUSED SMOKE DAMAGE TO THE FACILITY. SPAN-AMERICA HAS SHIPPED UNITS OF THE PRESSUREGUARD EASY AIR SINCE PRODUCT LAUNCH IN 2002, AND HAVE REC'D NO OTHER REPORTS OF INCIDENCES OF THIS NATURE. THE MFR OF THE POWER CORD, INTERPOWER CORP, HAS PROVIDED A REVIEW SUMMARIZING FIELD HISTORY FOR UNITS SOLD. A COPY OF THIS LETTER IS PROVIDED WITH THIS FORM, PAGES 3 AND 4. THE CORD SET IS RATED FOR 13 AMPS AND THE CONTROLLER UNIT PROTECTED WITH A DOUBLE FUSE RATED AT 1 AMP, PROVIDING A SAFETY MARGIN OF 13. THE FUSE HOUSING IS RATED FOR 10 AMPS. AT THIS TIME, SPAN HAS NOT PERFORMED AN INSPECTION ON THE CORD TO CONFIRM THAT IT IS THE ORIGINAL POWER CORD OR INVESTIGATE THE ROOT CAUSE OF THE INCIDENT.

    Description of Event or Problem · 1

    CNA WALKED INTO RESIDENT ROOM AND NOTICED FLAMES COMING FROM WALL NEAR THE OUTLET. THE FIRE WAS EXTINGUISHED. PT WAS NOT IN ROOM AT THE TIME, 2 EMPLOYEES WERE TREATED AT ER FOR SMOKE INHALATION AND RELEASED. THE FIRE DEPT AND AN OUTSIDE ELECTRICAL CO DETERMINED THE CAUSE OF THE FIRE TO BE A LOOSE CONNECTION INSIDE THE MODED ON CORD CAP OF THE PRESSUREGUARD EASY AIR MATTRESS, MFR'D BY SPAN-AMERICA MEDICAL SYSTEMS, INC. THE PRODUCT WAS PURCHASED BY THE FACILITY 2/5/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREGUARD EASY AIR LOW AIR LOSS MATTRESS FNM SPAN-AMERICA MEDICAL SYSTEMS, INC. 4000A *

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR