BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRELLA MED-SURG

    MDR report key: 13385891 · Received January 28, 2022

    Report

    Report Number
    1824206-2022-00027
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    January 11, 2022
    Report Date
    January 28, 2022
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    UDI-DI
    00887761985162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED A PATIENT DEVELOPED A STAGE 2 PRESSURE INJURY ON HIS RIGHT BUTTOCKS AND SACRUM DUE TO THE CENTRELLA MAX MATTRESS. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE INITIAL REPORT. FOLLOW UP INFORMATION WAS RECEIVED FROM THE CUSTOMER REGARDING THE REPORTED EVENT. THE CUSTOMER REPORTED THE PATIENT IS A (B)(6) MALE WEIGHING 112 KG ((B)(6)) WITH AN ADMITTING DIAGNOSIS OF SDH, SEPSIS, ENCEPHALOPATHY, AND ARF. THE PATIENT¿S MEDICAL HISTORY INCLUDES CAD, HTN, PROTEIN CALORIE MALNUTRITION, (B)(6). NO PRE-EXISTING PRESSURE INJURIES WERE NOTED UPON ADMISSION. THE PATIENT WAS KNOWN TO HAVE BEEN ON THE CENTRELLA BED SINCE (B)(6) 2022 AND A STAGE 2 SACRAL PRESSURE INJURY AND DEEP TISSUE INJURY (DTI) TO THE RIGHT BUTTOCK WAS NOTED ON (B)(6) 2022. THE CUSTOMER CONFIRMED NO SHEETS WERE BEING UTILIZED; HOWEVER, A COMFORT GLIDE SLIDER, COMFORT GLIDE PAD, AND ULTRASORB PAD WERE BEING UTILIZED. THE PATIENT WAS BEING TURNED EVERY 2 HOURS AS ORDERED WITH WEDGES AND PILLOWS. THE PRESSURE INJURY WAS BEING MANAGED WITH SACRAL MEPILEX BORDER DRESSING. IT WAS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS PROVIDED. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PATIENT¿S TREATMENT OR PROCEDURE DUE TO THE PRESSURE INJURY. THE BED DID NOT PROVIDE ANY AUDIBLE OR VISUAL ALERTS/MESSAGES PRIOR TO THE EVENT. THE CENTRELLA BED IS INTENDED FOR USE IN HEALTHCARE ENVIRONMENTS AS A PATIENT SUPPORT SYSTEM TO PREVENT AND/OR TREAT PRESSURE INJURIES. IT IS INTENDED FOR A BROAD PATIENT POPULATION AS DETERMINED APPROPRIATE BY THE CAREGIVER OR INSTITUTION. IT IS INTENDED FOR PATIENT POPULATIONS WEIGHING AT LEAST 70 LB (32 KG) AND IS CAPABLE OF SUPPORTING PATIENTS UP TO 500 LB (227 KG). THE CENTRELLA MAX MATTRESS IS A POWERED AIR MATTRESS THAT HAS A MICROCLIMATE MANAGEMENT (MCM) COVER THAT OPERATES CONTINUOUSLY WHILE THE PATIENT IS ON THE BED. MCM HELPS DECREASE LOCALIZED HEAT AND MOISTURE BUILDUP THAT OCCURS BETWEEN THE PATIENT AND THE MATTRESS. INSTRUCTIONS FOR USE STATE THE CENTRELLA MAX MATTRESS IS NOT A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE CENTRELLA MAX MATTRESS SHOULD BE USED IN CONJUNCTION WITH GOOD ASSESSMENT AND PROTOCOL. OTHERWISE, PATIENT INJURY COULD OCCUR. THE INSTRUCTION FOR USE PROVIDES THE USER WITH GUIDANCE ON HOW TO ADJUST THE CENTRELLA MAX MATTRESS PRESSURE SETTINGS USING THE MATTRESS MENU CONTROL LOCATED ON THE GRAPHICAL CAREGIVER CONTROL (GCI). 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. THE HILLROM SERVICE TECHNICIAN ARRIVED AT THE FACILITY ON (B)(6) 2022 TO INSPECT THE BED AND NOTED THE BED WAS STILL OCCUPIED BY THE SAME PATIENT WITH AN AIR FLOW PAD ONLY. THE PATIENT ADVISED THE TECHNICIAN THAT THERE WERE MORE LAYERS OF LINEN, BUT HE COULD NOT RECALL HOW MANY. THE TECHNICIAN ALSO NOTED THE P500 RENTAL MATTRESS THAT WAS DELIVERED THE DAY OF THE INCIDENT WAS OUTSIDE OF THE ROOM. THE TECHNICIAN PERFORMED COMPLETE FUNCTIONAL TESTING ON THE CENTRELLA BED, AND NO ISSUES WERE FOUND. THE BED FUNCTIONED AS DESIGNED PER FUNCTIONAL, AUDIBLE, AND VISUAL TESTING. A STAGE 2 PRESSURE INJURY IS CATEGORIZED AS PARTIAL THICKNESS LOSS OF DERMIS PRESENTING AS A SHALLOW OPEN ULCER WITH A RED-PINK WOUND BED, WITHOUT SLOUGH. A STAGE 2 PRESSURE INJURY MAY ALSO PRESENT AS AN INTACT OR OPEN/RUPTURED SERUM-FILLED OR SEROSANGUINOUS FILLED BLISTER AND IS CONSIDERED A MODERATE INJURY. TREATMENT MAY INCLUDE REMOVING PRESSURE FROM THE WOUND AND CLEANING THE SORE WITH WATER OR MILD, STERILE SALTWATER SOLUTION TO DRY OUT THE WOUND. A STAGE 2 PRESSURE INJURY IS NOT CONSIDERED A SERIOUS INJURY AND IS NOT REPORTABLE. DTI IS AN INJURY TO THE SOFT TISSUE UNDER THE SKIN DUE TO PRESSURE AND IS USUALLY OVER BONEY PROMINENCE. A DTI IS CONSIDERED A SERIOUS INJURY BECAUSE IT CAN BE LIFE THREATENING, RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR CAN NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THIS EVENT IS LIKELY DUE TO MULTIPLE LAYERS OF LINEN/PADS BEING USED WITH THE PATIENT ON THE DEVICE. STUDIES SHOW THE PRESENCE OF LINENS ON THE BED SURFACE GENERALLY ADVERSELY AFFECT THE PRESSURE REDISTRIBUTION CAPABILITIES OF THE SURFACE ON WHICH THEY ARE PLACED. CAREGIVERS SHOULD LIMIT THE PRESENCE OF LINENS ON THE SURFACE TO PRODUCTS THAT ARE NECESSARY. INSPECTION OF THE DEVICE FOUND NO MALFUNCTION, HOWEVER DUE TO THE DTI, HILLROM DEEMS THIS A REPORTABLE SERIOUS INJURY DUE TO POTENTIAL USER ERROR AND THE SERIOUS INJURY INVOLVED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED A PATIENT DEVELOPED A STAGE 2 PRESSURE INJURY ON HIS RIGHT BUTTOCKS AND SACRUM DUE TO THE CENTRELLA MAX MATTRESS. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE INITIAL REPORT. FOLLOW UP INFORMATION WAS RECEIVED FROM THE CUSTOMER REGARDING THE REPORTED EVENT. THE CUSTOMER REPORTED THE PATIENT IS A (B)(6) MALE WEIGHING 112 KG ((B)(6)) WITH AN ADMITTING DIAGNOSIS OF SDH, SEPSIS, ENCEPHALOPATHY, AND ARF. THE PATIENT¿S MEDICAL HISTORY INCLUDES CAD, HTN, PROTEIN CALORIE MALNUTRITION, (B)(4). NO PRE-EXISTING PRESSURE INJURIES WERE NOTED UPON ADMISSION. THE PATIENT WAS KNOWN TO HAVE BEEN ON THE CENTRELLA BED SINCE (B)(6) 2022 AND A STAGE 2 SACRAL PRESSURE INJURY AND DEEP TISSUE INJURY (DTI) TO THE RIGHT BUTTOCK WAS NOTED ON (B)(6) 2022. THE CUSTOMER CONFIRMED NO SHEETS WERE BEING UTILIZED; HOWEVER, A COMFORT GLIDE SLIDER, COMFORT GLIDE PAD, AND ULTRASORB PAD WERE BEING UTILIZED. THE PATIENT WAS BEING TURNED EVERY 2 HOURS AS ORDERED WITH WEDGES AND PILLOWS. THE PRESSURE INJURY WAS BEING MANAGED WITH SACRAL MEPILEX BORDER DRESSING. IT WAS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS PROVIDED. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PATIENT¿S TREATMENT OR PROCEDURE DUE TO THE PRESSURE INJURY. THE BED DID NOT PROVIDE ANY AUDIBLE OR VISUAL ALERTS/MESSAGES PRIOR TO THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510457 CENTRELLA MED-SURG BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P7900B200011 00887761985162

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other