BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY AIR II (RENTED)

    MDR report key: 394687 · Received May 14, 2002

    Report

    Report Number
    394687
    Event Type
    Injury
    Date Received
    May 14, 2002
    Date of Event
    April 19, 2002
    Report Date
    May 14, 2002
    Manufacturer
    MEDIQ PRN
    Product Code
    INX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MOTOR ON FOOT OF AIR BED FOUND TO BE HOT TO TOUCH. FLUID BLISTER TO RIGHT GREAT TOE APPROX QUARTER SIZED ON THE POSTER TOE. PURPLE DISCOLORATION AND BLISTER COVERING THE BALL OF RIGHT FOOT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 07/08/2002: MEDIQ/PRN HAS INFORMED THE FDA THAT IT CEASED THE PRODUCTION OF AIR-FLUIDIZED BEDS AND AIR-FLOTATION MATTRESSESS UNDER THE TRADE NAME OF MEDIQ FST ON 11/01/2000 AND CHANGED THEIR REGISTRATION ACCORDINGLY. AS YOU CAN SEE ON THE FDA ESTABLISHMENT REGISTRATION DATABASE, MFR IS NOW REGISTERED ONLY AS A CONTACT MFR AND REBUILDER/REFURBISHER (REGISTRATION #2028610). ELEVEN TEMPERATURE READINGS WERE OBTAINED AT VARIOUS POINTS OF THE UNIT'S TOP AND BACK (TOWARD THE PT). THE VALUES RANGED FROM 89.6 F. TO 95.0 F. MFR'S CONCLUSION FROM THESE TEMPERATURE READINGS IS THAT THE BLISTER AND SKIN DISCOLORATION REPORTED BY THE FACILITY WERE NOT CAUSED BY THE OVERHEATING OF THE UNIT. THE TEMPERATURE RANGES OBSERVED ARE WITHIN THE NORMAL OPERATING RANGES AND WELL BELOW THOSE ALLOWED BY THE UL-544 STANDARD (158 F. FOR METAL AND 185 F. FOR NON-METAL SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY AIR II (RENTED) AIR MATTRESS INX MEDIQ PRN 544 SYNERGY AIR *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention