BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CNTROLR, RNT CLRT 120V US

    MDR report key: 19630583 · Received June 27, 2024

    Report

    Report Number
    1824206-2024-00876
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    April 14, 2024
    Report Date
    June 27, 2024
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    OSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER MEDWATCH REPORT WAS RECEIVED ALLEGING THE MATTRESS ON THE COMPELLA BARIATRIC BED WAS NOT INFLATING AND THE PATIENT DEVELOPED A STAGE 4 PRESSURE INJURY. THE PATIENT IN THIS EVENT IS A 67-YEAR-OLD WHITE FEMALE WEIGHING 494 LB WITH A MEDICAL HISTORY OF COPD, OBESITY BMI 114, OHS/OSA WITH CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ON AVAPS. ON AN UNREPORTED DATE, THE PATIENT WAS ADMITTED FOR ACUTE RESPIRATORY FAILURE AND PLACED ON A COMPELLA BARIATRIC BED ON MAX INFLATE MODE. ON (B)(6) 2024, WOUND CARE WAS CONSULTED WHEN STAFF NOTICED DISCOLORATION TO THE PATIENT¿S LEFT BUTTOCKS. WHEN STAFF ASSESSED THE PATIENT, THEY NOTED THE MATTRESS WAS NOT INFLATING, LEAVING THE PATIENT¿S BUTTOCKS WITHOUT A CUSHION BETWEEN HER AND THE BEDFRAME. IT IS UNKNOWN HOW LONG THE BED WAS MALFUNCTIONING, BUT IT WAS IMMEDIATELY EXCHANGED WHEN IDENTIFIED. THE INJURY EVOLVED INTO A STAGE 4 PRESSURE INJURY, WHICH DEVELOPED A NECROTIZING SOFT TISSUE INFECTION AND CAUSE THE PATIENT TO BECOME SEPTIC ON (B)(6) 2024. THE PATIENT HAS SINCE UNDERGONE SIX SURGICAL DEBRIDEMENT¿S OF THE WOUND WITH A WOUND VACUUM PLACED ON (B)(6) 2024. 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 DEVICE INSTRUCTIONS FOR USE (IFU) STATE MAX INFLATE MODE INFLATES THE SURFACE ASSEMBLY TO ITS MAXIMUM PRESSURES AND SHOWS A 30-MINUTE COUNTDOWN ON THE MAX INFLATE SCREEN. A MAX INFLATE TIMEOUT ALARM WILL OCCUR 29 MINUTES AFTER MAX INFLATE IS STARTED. IF THE UNIT DETECTS AN ALARM CONDITION IN THE (THERAPY) SURFACE, THE SYSTEM ALARM SCREEN SHOWS AND DISPLAYS THE EXTENDED SET OF PRESSURES. DIFFERENT ALARMS ARE GENERATED BY THE AIR SUPPLY UNIT TO NOTIFY THE CAREGIVER OF POTENTIALLY HAZARDOUS CONDITIONS. THE DEVELOPMENT OF PRESSURE INJURIES IS MULTIFACTORIAL AND CANNOT ONLY BE ATTRIBUTED TO THE PERFORMANCE OF THE SURFACE OR THE COMPELLA BED. PRESSURE INJURIES CAN DEVELOP WITHIN 2-6 HOURS WHEN CAPILLARIES SUPPLYING THE SKIN AND SUBCUTANEOUS TISSUES ARE COMPRESSED, CAUSING AN OBSTRUCTION IN BLOOD FLOW, WHICH ULTIMATELY LEADS TO TISSUE NECROSIS. POSITION CHANGES ARE KEY TO PRESSURE INJURY 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. PREVENTION OF PRESSURE INJURIES INVOLVES A MULTIDISCIPLINARY APPROACH INCLUDING RAPID IDENTIFICATION OF AT-RISK INDIVIDUALS SUCH AS THOSE WITH DIABETES, INCONTINENCE, IMPAIRED MOBILITY, PERIPHERAL VASCULAR DISEASE, ETC., AND EXERCISING A VIGILANT PREVENTION PROTOCOL CONSISTING OF SKINCARE, NUTRITIONAL ASSESSMENT REDUCING MECHANICAL LOAD, AND UTILIZING SUPPORT SURFACES. A STAGE 4 PRESSURE INJURY EXTENDS TO THE MUSCLE, BONE, OR JOINTS AND CAN CAUSE A SERIOUS INFECTION OF THE BONE, KNOWN AS OSTEOMYELITIS. IN THIS EVENT, THE PATIENT DEVELOPED A STAGE 4 PRESSURE INJURY THAT DEVELOPED INTO NECROTIZING SOFT TISSUE INFECTION AND SEPSIS REQUIRING MEDICAL AND SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, CONCLUDING A SERIOUS INJURY OCCURRED. AN INSPECTION OF THE DEVICE IS PENDING, AND A DEVICE MALFUNCTION CANNOT BE RULED OUT. THE COMPLAINT WILL BE REASSESSED IF ADDITIONAL INFORMATION IS RECEIVED. 24JUN2024 UPDATE: BAXTER INSPECTED THE COMPELLA BED, AND THE BED FUNCTIONED AS DESIGNED. NO ISSUE WAS FOUND WITH THE BED, BLOWER, OR MATTRESS. THE PATIENT WAS REPORTEDLY ON THE BED FOR ONE DAY. THE BAXTER SERVICE TECHNICIAN SWAPPED THE BED AT THE REQUEST OF THE ACCOUNT. BAXTER DID NOT BECOME AWARE OF THE REPORTED EVENT UNTIL 31MAY2024, AND THE BED INSPECTION DID NOT TAKE PLACE FOR ALMOST TWO MONTHS AFTER THE INCIDENT. OF NOTE, A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO COMPLAINTS THAT ALIGN WITH THE DATE OF OCCURRENCE. IN THIS EVENT, THE EXACT CAUSE OF THE PATIENT¿S SERIOUS INJURY IS UNDETERMINED; HOWEVER, NO MALFUNCTION OF THE COMPELLA BED WAS IDENTIFIED DURING INSPECTION BY BAXTER.

    Description of Event or Problem · 0

    A CUSTOMER MEDWATCH REPORT WAS RECEIVED ALLEGING THE MATTRESS ON THE COMPELLA BARIATRIC BED WAS NOT INFLATING AND THE PATIENT DEVELOPED A STAGE 4 PRESSURE INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828562 CNTROLR, RNT CLRT 120V US BARIATRIC BED OSI HILL-ROM BATESVILLE P7810ARC3A0ENG1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other