BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPELLA AIR MATTRESS, NA, R

    MDR report key: 12742204 · Received November 3, 2021

    Report

    Report Number
    1824206-2021-00524
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 3, 2021
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    OSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION FROM THE CUSTOMER WERE UNSUCCESSFUL. THE COMPELLA BARIATRIC BED SYSTEM IS INTENDED TO PROVIDE PATIENT SUPPORT IN HEALTH CARE ENVIRONMENTS AND 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). IT IS CAPABLE OF BEING USED WITH A BROAD PATIENT POPULATION AS DETERMINED APPROPRIATE BY THE CAREGIVER OR INSTITUTION AND IS INTENDED FOR PATIENTS BETWEEN 113 KG AND 454 KG (250 LB AND 1000 LB). THE HILLROM SERVICE TECHNICIAN ARRIVED AT THE CUSTOMER ACCOUNT TO INITIATE A SWAP OF THE BED. THE CUSTOMER REFUSED THE SWAP BECAUSE IT WAS A SMALLER BED THAN THE PATIENT CURRENTLY HAD. WHILE ON THE UNIT, THE NURSE REQUESTED AN IN-SERVICE ON THE ROTATION FEATURE BECAUSE THE STAFF WAS GOING TO HAVE TO ROTATE THE PATIENT. THE HILLROM SERVICE TECHNICIAN DEMONSTRATED THE TURN ASSIST FUNCTIONS AND THE BED WAS NOT MALFUNCTIONING DURING THE TIME THE SERVICE TECHNICIAN WAS ON THE UNIT. THE BED STARTED TO MALFUNCTION AFTER THE SERVICE TECHNICIAN LEFT AND THE REPAIR WAS CALLED IN LATE AFTERNOON ON 18OCT2021. WOUND CARE CALLED HILLROM TO INQUIRE ABOUT AN ENVELLA BED FOR THE PATIENT OVER (B)(6). THE CUSTOMER WAS INFORMED THE PATIENT EXCEEDED THE WEIGHT LIMIT FOR THE ENVELLA BED. A TOTALCARE BARIATRIC BED WAS ORDERED AND DELIVERED TO THE CUSTOMER ON 18OCT2021 AND SAT UNUSED UNTIL THE NEXT DAY WHEN THE CUSTOMER TOLD THE SERVICE TECHNICIAN IT WAS TOO SMALL FOR THE PATIENT. THE HILLROM SERVICE TECHNICIAN RECEIVED A CALL FROM WOUND CARE THAT THE BED WOULD NOT GO INTO ROTATION. THE CUSTOMER AGAIN INQUIRED ABOUT AN ENVELLA BED AND WAS TOLD THE PATIENT EXCEEDED THE WEIGHT LIMIT. A REPLACEMENT COMPELLA BED WAS DELIVERED AND THE BED THAT WAS MALFUNCTIONING WAS SWAPPED. INSPECTION OF THE COMPELLA BED FOUND THE TURN BLADDER LEAKING AT THE HOSE CONNECTION. THE BLADDER WAS REPLACED, AND THE BED WAS FUNCTIONING AS DESIGNED POST-REPAIR. IT IS UNLIKELY THE MALFUNCTION WOULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. 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 III PRESSURE ULCER INVOLVES FULL THICKNESS SKIN LOSS THAT OFTEN REQUIRES MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT AND THEREFORE MEETS THE DEFINITION OF A SERIOUS INJURY. HILLROM CONSIDERS THE DEVELOPMENT OF A STAGE III PRESSURE ULCER A REPORTABLE SERIOUS INJURY. A SEARCH OF THE HILLROM MAINTENANCE RECORDS DID NOT SHOW HILLROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE TURN ASSIST BLADDER SYSTEM TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE BED TURN BLADDER WAS NOT ROTATING A FULL CYCLE AND THE PATIENT DEVELOPED A STAGE III PRESSURE ULCER ON HIS SACRUM. PER THE CUSTOMER, THE PATIENT WAS ADMITTED WITH NO PRE-EXISTING ULCERS. THE MATTRESS WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641581 COMPELLA AIR MATTRESS, NA, R BARIATRIC BED OSI HILL-ROM BATESVILLE P642AREN0100000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other