BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRESSA FRAME

    MDR report key: 15699468 · Received October 31, 2022

    Report

    Report Number
    1824206-2022-00475
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    October 10, 2022
    Report Date
    October 31, 2022
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT FOR APPROXIMATELY ONE YEAR THE PROGRESSA WAS MAKING AN ¿ODD NOISE,¿ WRENCH LIGHT VISUAL APPEARING INTERMITTENTLY, AND RECENTLY THE BED WAS NOTED AS ¿HARD,¿ WITH THE PATIENT DEVELOPING A STAGE 4 PRESSURE INJURY (PI) TO HIS LEFT HIP. THE PI WAS NOTED APPROXIMATELY 6-8 MONTHS AGO, THE PATIENT WAS HOSPITALIZED, PLACED ON ANTIBIOTICS AND A WOUND VAC. THE PATIENT IS A 28-YEAR-OLD MALE, WEIGHING 125 POUNDS WITH A MEDICAL HISTORY OF SPINA BIFIDA. THE PATIENT'S MOTHER STATES THEY HAVE HAD THE DEVICE FOR HOME USE SINCE 2016. SHE CONVEYED HER SON HAD ONE PREVIOUS PI (12 YEARS AGO) AND HAS HAD NONE UNTIL THE RECENT STAGE 4 ALLEGED. THE PATIENT IS HOME, AND THE WOUND IS CURRENTLY HEALING (NOW A STAGE 3), WITH WOUND CARE CONTINUING TO MONITOR. A DEVICE INSPECTION WAS REQUESTED. THE PROGRESSA BED IS INTENDED TO BE USED TO TREAT OR PREVENT PULMONARY OR OTHER COMPLICATIONS ASSOCIATED WITH IMMOBILITY; TO TREAT OR PREVENT PRESSURE ULCERS; OR FOR ANY OTHER USE WHERE MEDICAL BENEFITS MAY BE DERIVED FROM EITHER CONTINUOUS LATERAL ROTATION THERAPY OR PERCUSSION/VIBRATION THERAPY. THE PROGRESSA BED IS INTENDED TO PROVIDE A PATIENT SUPPORT TO BE USED IN HEALTH CARE ENVIRONMENTS. THE PROGRESSA BED MAY BE USED IN A VARIETY OF SETTINGS INCLUDING, BUT NOT LIMITED TO, ACUTE CARE, INCLUDING CRITICAL CARE, STEP DOWN/PROGRESSIVE CARE, MEDICAL/SURGICAL, HIGH ACUITY SUB-ACUTE CARE, POST ANESTHESIA CARE UNIT (PACU), AND SECTIONS OF THE EMERGENCY DEPARTMENT (ED). THE PROGRESSA BED IS CAPABLE OF BEING USED WITH A BROAD PATIENT POPULATION AS DETERMINED APPROPRIATE BY THE CAREGIVER OR INSTITUTION. INSPECTION OF THE DEVICE BY A HILLROM TECHNICIAN COULD NOT FIND ANY MALFUNCTIONS AND THE PROGRESSA WAS NOTED TO BE FUNCTIONING AS DESIGNED. NO MALFUNCTIONS WERE FOUND WITH THE BLOWER BOX ASSY/ COMPRESSOR (AIR SUPPLY FOR THE MATTRESS). THE LOUD ¿WINDING SOUND¿ WAS STATED TO BE COMING FROM THE PULMONARY BOX SUPPORT FEATURE (PERCUSSION, VIBRATION, AND ROTATION). THE TECHNICIAN STATED THESE BEARINGS WOULD NOT COMPROMISE THE DEVICE; HOWEVER, HE DID RECOMMEND TO THE CUSTOMER FOR THIS TO BE CHANGED. THE MATTRESS WAS IN RANGE OF THE SET POINT AND ACTUAL SETTING - HEAD, SEAT, AND FOOT BLADDERS. SCALE WAS ACCURATE. A FACTORY RESET WAS ALSO PERFORMED. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE SERVICE WRENCH (NOTED BY CUSTOMER) TO DIAGNOSE TYPE OF ERROR. THE MOTHER HAS OPTED TO NOT CHANGE OUT THE DEVICE BEARINGS AT THIS TIME DUE TO THIS NOT COMPRISING THE DEVICE. 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), 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 NEED TO MINIMIZE THE RISK OF PRESSURE ON VULNERABLE AREAS. A STAGE 4 PI INVOLVES FULL THICKNESS SKIN AND TISSUE LOSS WITH EXPOSED OR DIRECTLY PALPABLE FASCIA, SLOUGH, MUSCLE, TENDON, LIGAMENT, CARTILAGE, OR BONE IN THE ULCER. TREATMENT CAN BEGIN WITH REMOVAL OF THE DEAD TISSUE AND IF THE DAMAGE IS EXTENSIVE, SURGERY IS USUALLY REQUIRED. THE REPORTED STAGE 4 PI (SERIOUS INJURY) REQUIRED MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE PI COULD LIKELY BE RELATED TO ANY OF THE FOLLOWING OR THE COMBINATION THEREOF: THE PATIENT¿S DISEASE PROCESS/CO-MORBIDITIES, INCLUDING HISTORY OF SPINA BIFIDA AND HOME POSITIONING ON THE DEVICE. THE BED WAS INSPECTED AND NOTED TO BE FUNCTIONING AS DESIGNED, HOWEVER THE DEVICE CAUSING OR CONTRIBUTING TO THE SERIOUS INJURY CANNOT BE RULED OUT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOR APPROXIMATELY ONE YEAR THE PROGRESSA WAS MAKING AN ¿ODD NOISE,¿ WRENCH LIGHT VISUAL APPEARING INTERMITTENTLY, AND RECENTLY THE BED WAS NOTED AS ¿HARD,¿ WITH THE PATIENT DEVELOPING A STAGE 4 PRESSURE INJURY (PI) TO HIS LEFT HIP. THE PI WAS NOTED APPROXIMATELY 6-8 MONTHS AGO, THE PATIENT WAS HOSPITALIZED, PLACED ON ANTIBIOTICS AND A WOUND VAC. THE BED WAS LOCATED AT THE PATIENTS 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
    2419042 PROGRESSA FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P7500A000539

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other