BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECLIPSE ASSEMBLY

    MDR report key: 3843778 · Received May 28, 2014

    Report

    Report Number
    1824206-2014-01651
    Event Type
    Other
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN PERFORMED THE INVESTIGATION AND THE CAREGIVER ESTATE THE HIP SECTION OF AIR MATTRESS LOSES AIR PRESSURE WHEN THE PATIENTS HEAD SECTION IS ELEVATED CAUSING THE PATIENT TO FALL TO HIS RIGHT SIDE. THE PATIENT WAS TREATED IN HOSPITAL FOR BED SORES. THE TECHNICIAN INSPECTED THE UNIT AND FOUND THE ZONE 3 PROPORTIONAL VALVE HAD LOW PRESSURE WITH A READING OF 6.7. NO SERVICE LIGHT CAME ON WHILE INSPECTING THE BED. THE TECHNICIAN RESTARTED THE UNIT AND CHECKED PRESSURE AND UNIT IS NOW FUNCTIONING AS DESIGNED. A HILL-ROM REPRESENTATIVE CALLED AND SPOKE WITH THE PATIENT TO ASK ABOUT THE ALLEGATION OF A NEW PRESSURE SORE DEVELOPING. THE PATIENT STATED THAT THE BED WAS NOT FUNCTIONING CORRECTLY AND HE HAS DEVELOPED A NEW SORE ON HIS LEFT SIDE. THE PATIENT DID SEEK MEDICAL TREATMENT AND HIS SORE IS A STAGE 4 PRESSURE ULCER. HE WAS GIVEN MEDICINE AND A 6 WEEK IV. THE PATIENT CONFIRMED HE HAS SUFFERED FROM PREEXISTING PRESSURE ULCERS AND HAS HAD SURGERY ON THEM. THE HILL-ROM REPRESENTATIVE INSERVICE THE PATIENT ON THE IMPORTANCE OF PATIENT POSITIONING TO ENSURE PROPER AIR FLOW DURING USE OF THE MATTRESS. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. DEVELOPMENT OF PRESSURE ULCERS IS MULTIFACTORIAL AND CANNOT BE ONLY ATTRIBUTED TO PERFORMANCE OF THE SURFACE. RISK FACTORS INCLUDE PROTEIN-CALORIE MALNUTRITION, MICROCLIMATE (SKIN WETNESS CAUSED BY SWEATING OR INCONTINENCE), DISEASE THAT REDUCE BLOOD FLOW TO THE SKIN, SUCH AS ARTERIOSCLEROSIS, OR DISEASES THAT REDUCE THE SENSATION IN THE SKIN, SUCH AS PARALYSIS OR STRESS ON THE SKIN, THE BODY POSITIONS NEED TO MINIMIZE THE RISK OF PRESSURE ON VULNERABLE AREAS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED HE DEVELOPED A PRESSURE SORE THAT HE BELIEVES WAS CAUSED BY THE MATTRESS NOT FUNCTIONING PROPERLY. THE MATTRESS IS LOCATED IN THE PATIENT'S HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314234 ECLIPSE ASSEMBLY BED FLOTATION THERAPY POWERED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization