BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRESSA BED

    MDR report key: 4960968 · Received July 30, 2015

    Report

    Report Number
    1824206-2015-00770
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE TOPPER COVERS DIMENSIONS TO LARGE CAUSING THE APPEARANCE OF FOLDS BY THE SACRUM WHEN THE BACKREST IS UP. THE HILL-ROM TECHNICIAN REPLACED THE BED WITH ANOTHER PROGRESSA BED. THE MCM TOPPER WAS ALSO REPLACED AS WELL. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. DEVELOPMENT OF PRESSURE ULCERS IS MULTIFACTORIAL AND CANNOT BE ONLY ATTRIBUTE TO PERFORMANCE OF THE SURFACE. RISK FACTORS INCLUDE PROTEIN-CALORIE MALNUTRITION, MICROCLIMATE (SKIN WETNESS CAUSED BY SWEATING OR INCONTINENCE), DISEASES THAT REDUCE BLOOD FLOW TO THE SKIN, SUCH AS ARTERIOSCLEROSIS, OR DISEASES THAT REDUCE THE SENSATION IN THE SKIN, SUCH AS PARALYSIS OR NEUROPATHY. POSITION CHANGES ARE KEY TO PRESSURE SORE PREVENTION AND TREATMENT. THESE CHANGES NEED TO BE FREQUENT, REPOSITIONING NEEDS TO AVOID STRESS ON THE SKIN, AND BODY POSITIONS NED TO MINIMIZE THE RISK OF PRESSURE ON VULNERABLE AREAS.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE COVER THAT WAS DELIVERED WITH THE PROGRESSA BED WAS TOO LARGE AND HAD FOLDS ON THE SACRUM AREA OF THE COVER WHEN BACKREST OF THE DEVICE IS UP. THE PT ACQUIRED A SACRUM BED SORE. THE PT IS BEING TREATED BY THE MEDICAL STAFF. THE BED IS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495482 PROGRESSA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 7500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other