BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREASSIST ES100/200/400

    MDR report key: 17576121 · Received August 18, 2023

    Report

    Report Number
    3006697241-2023-00085
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 18, 2023
    Manufacturer
    HILL-ROM MEXICO
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SEAT SECTION OF THE ACCUMAX SURFACE THAT WAS ON THE CARE ASSIST FRAME HAD SUNK AND THE PATIENT DEVELOPED SKIN BREAKDOWN. DURING A FOLLOW-UP PHONE CALL WITH THE PATIENT, THE PATIENT STATED THAT TWO PREEXISTING HEALED PRESSURE INJURIES HAD REOPENED. THE PRESSURE INJURIES WERE REPORTED TO BE STAGE 2, ONE LOCATED ON THE COCCYX AND THE OTHER ON THE ISCHIUM. THIS PATIENT IS A HOMECARE PATIENT WITH A HISTORY OF PARAPLEGIA (20+YEARS) AND INCONTINENCE. THE PATIENT HAS BEEN USING THE CARE ASSIST FRAME WITH THE ACCUMAX SURFACE SINCE (B)(6) 2023. THE PATIENT REPORTED THAT SHE CURRENTLY SEES HOME HEALTH THREE TIMES A WEEK AND WOUND CARE ONCE A WEEK. HOME HEALTH VISITS AND REPORTS THAT THE PRESSURE INJURIES ARE DEBRIDED, AND GENTAMYCIN SULFATE OINTMENT AND A HYDROFERA BLUE DRESSING ARE APPLIED. THE ACCUMAX MATTRESS IS A THERAPEUTIC PRESSURE REDISTRIBUTION SYSTEM COMPRISED OF FOAM-FILLED AIR CYLINDERS THAT AID IN THE PREVENTION/TREATMENT OF PRESSURE INJURIES IN PATIENTS AND RESIDENTS WITH UP TO MODERATE RISK AND/OR STAGE I AND II PRESSURE INJURIES WHEN COMBINED WITH RECOMMENDED TURNING PROTOCOLS. THE ACCUMAX MATTRESS CAN SUPPORT A PATIENT WEIGHT UP TO 500 LB (227 KG). THE DEVELOPMENT OF PRESSURE INJURIES IS MULTIFACTORIAL AND CANNOT ONLY BE ATTRIBUTED TO THE PERFORMANCE OF THE SURFACE. 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 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 2 PRESSURE INJURY IS CHARACTERIZED BY PARTIAL-THICKNESS SKIN LOSS NO DEEPER THAN THE DERMIS AND CAN INCLUDE INTACT OR RUPTURED BLISTERS. STAGE 2 PRESSURE INJURIES CAN HEAL VERY RAPIDLY THEREFORE TREATMENT IS FOCUSED ON NUTRITION TO SUPPORT WOUND HEALING AND KEEPING THE AREA PROTECTED/COVERED AND CLEAN. IN THIS EVENT, THE REPORTED STAGE 2 PRESSURE INJURIES WERE REPORTED TO HAVE MEDICAL INTERVENTION WHICH INCLUDED ANTIBIOTIC OINTMENT, ANTIBIOTIC PAD, AND DEBRIDEMENT. DEBRIDEMENT IS USED TO REMOVE NECROTIC TISSUE FROM A DEEP OR SEVERE WOUND TO PROMOTE THE HEALING PROCESS. IT IS NECESSARY ON CHRONIC WOUNDS THAT ARE NOT HEALING PROPERLY OR WOUNDS THAT ARE AT RISK OF INFECTION. THUS, THE REPORTED MEDICAL INTERVENTION OF DEBRIDEMENT FOR PRESSURE INJURIES INDICATES THAT A SERIOUS INJURY OCCURRED. THE DEVICE IFU NOTES THAT THE EXPECTED LIFE OF THE ACCUMAX MATTRESS IS FIVE YEARS OF NORMAL USE PROVIDED THAT RECOMMENDED PREVENTIVE MAINTENANCE IS PERFORMED. AT THIS TIME, AN INSPECTION OF THE MATTRESS IS PENDING, IF ANY RELEVANT INFORMATION IS RECEIVED, THE COMPLAINT WILL BE ADDRESSED ACCORDINGLY. CLINICAL EVALUATION REVISED (B)(6) 2023 WITH THE RECEIPT OF ADDITIONAL DETAILS. IT WAS ORIGINALLY REPORTED THAT THE PATIENT DEVELOPED TWO STAGE 2 PRESSURE INJURIES THAT REQUIRED MEDICAL INTERVENTION INCLUDING DEBRIDEMENT, ANTIBIOTIC OINTMENT AND ANTIBIOTIC PAD. THE REPORTED MEDICAL INTERVENTION OF DEBRIDEMENT FOR PRESSURE INJURIES INDICATES THAT A SERIOUS INJURY OCCURRED. THE INSPECTION PERFORMED BY A HILLROM TECHNICIAN NOTED THE SURFACE TO BE "SUNKEN IN ON THE UPPER LEFT SIDE." THE SURFACE WAS THEN REPLACED. THE DEVELOPMENT OF PRESSURE INJURIES IS MULTIFACTORIAL AND CANNOT ONLY BE ATTRIBUTED TO THE PERFORMANCE OF THE SURFACE. THE CAUSE OF THE REPORTED PRESSURE INJURIES IS UNKNOWN, IT CANNOT BE RULED OUT THAT THE "SUNKEN" MATTRESS DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEAT SECTION OF THE ACCUMAX SURFACE HAD SUNK AND THE PATIENT DEVELOPED SKIN BREAKDOWN. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127409 CAREASSIST ES100/200/400 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM MEXICO P1170E0000042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown