BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50")

    MDR report key: 19538911 · Received June 14, 2024

    Report

    Report Number
    3005857264-2024-00002
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 14, 2024
    Manufacturer
    AUGUSTINE TEMPERATURE MANAGEMENT LLC
    Product Code
    DWJ
    UDI-DI
    00855913001527
    PMA / PMN Number
    K092807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT MISUSE WAS THE ROOT CAUSE OF THE REPORTED PATIENT INJURY. THE PRODUCT WAS MISUSED IN THREE SEPARATE WARNED-AGAINST WAYS: EXPIRED PRODUCT, DAMAGED SHELL, AND REPEATEDLY RESETTING ALARMS. THE MATTRESS WAS EXPIRED WHEN THE PATIENT INJURY OCCURRED. THE IFU WARNS "DO NOT CONTINUE TO USE WARMING MATTRESSES BEYOND THE LABELED EXPIRATION DATE, FOUND ON THE CABLE". COMPANY CUSTOMER SERVICE RECORDS INDICATE THAT THE CUSTOMER WAS CONTACTED TWO SEPARATE TIMES ABOUT REPLACING THE EXPIRED MATTRESS AND EXPLICITLY CHOSE NOT TO DO SO. THE MATTRESS HAD EXTENSIVE DAMAGE TO THE SHELL:183 PINHOLES/CUTS WERE OBSERVED ON THE UPPER SURFACE. ABOUT 54 HOLES/CUTS WERE EASILY VISIBLE TO THE NAKED EYE. THIS MATTRESS SHOULD HAVE BEEN REMOVED FROM SERVICE AND DISCARDED DUE TO THIS UPPER SHELL LAYER DAMAGE. THE IFU WARNS, "INSPECT SYSTEM COMPONENTS PRIOR TO EACH USE FOR SIGNS OF DAMAGE OR EXCESSIVE WEAR SUCH AS CUTS, HOLES, OR LOOSE ELECTRICAL CONNECTIONS OR COLD AREAS. IF SIGNS OF WEAR ARE EVIDENT OR IF THE WARMING DEVICE HAS BEEN SUBJECTED TO EXTREME PHYSICAL FORCE (E.G. PINCHED BY CLAMPS OR RUN OVER BY CARTS), DO NOT USE THE DEVICE UNTIL IT HAS BEEN INSPECTED BY TECHNICAL STAFF." THE CUSTOMER REPORTED THAT THE MATTRESS HAD BEEN E2 ALARMING, INCLUDING DURING THE PROCEDURE OF THE REPORTED INCIDENT. THE E2 ALARM INDICATES A FAILURE TO REACH THE SET TEMPERATURE WITHIN 10 MINUTES. THE IFU WARNS: "DO NOT CONTINUE TO USE THE SYSTEM IF THE OVER-TEMPERATURE INDICATOR AND/OR ANY OTHER ALARMS CONTINUE TO SOUND AFTER RESET. REFER TO THE "ALARMS AND ALERTS" SECTION OF THIS MANUAL FOR MORE INFORMATION." SPECIFIC INFORMATION ABOUT THE E2 ALARM IS DESCRIBED IN THE ALARMS AND ALERTS SECTION OF THE CONTROLLER MANUAL: "WHEN THE WARMING DEVICE DOES NOT REACH THE TEMPERATURE SET POINT WITHIN 10 MINUTES, THE ALARM SOUNDS, AND POWER IS REMOVED FROM THE DEVICE. CHECK TO MAKE SURE THE DEVICE IS IN CONTACT WITH A PATIENT AND THE SENSOR AREA IS TOUCHING THE PATIENT. FEEL THE BLANKET OR MATTRESS FOR UNEVEN TEMPERATURES ON THE WARMING SURFACE AND DO NOT USE IF COLD OR HOT SPOTS DETECTED. UNPLUG THE DEVICE AND RECONNECT TO RESET. IF THE ALARM OCCURS AGAIN, STOP USING THE DEVICE AND CONTACT TECHNICAL SUPPORT." HAD THE PRODUCT NOT BEEN DAMAGED AND MISUSED, THERE WOULD BE NO PATIENT INJURY. DESPITE THE ISOLATED SLIGHTLY HIGHER TEMPERATURES CAUSED BY THE PRODUCT DAMAGE, THE INJURY WOULD NOT HAVE OCCURRED EVEN WITH THE DAMAGE HAD THE TISSUE IN CONTACT WITH THAT AREA BEEN ADEQUATELY PERFUSED. THIS FACT IS EVIDENCED BY THE ABSENCE OF THERMAL INJURY TO THE SKIN OF THE POSTERIOR THIGH (WITH NORMAL PERFUSION) THAT WAS IN CONTACT WITH THE WARMEST PART OF THE MATTRESS DURING THE FIRST HOURS OF THE PROCEDURE. THE PATIENT'S SPIRAL THIGH LIFT, LIPOSUCTION, AND SKIN-TIGHTENING LIKELY MECHANICALLY DAMAGED THE SUBDERMAL VASCULAR PLEXUS, COMPROMISING CUTANEOUS BLOOD FLOW. APPLYING VASOCONSTRICTIVE DRUGS TO THE SUBDERMAL AREA ALREADY EXPERIENCING A COMPROMISED BLOOD FLOW COMPOUNDED THE PROBLEM, WHICH ADVERSELY AND SEVERELY AFFECTED PERFUSION OF THE SKIN ON THE THIGH. THE MATTRESS IFU CONTRAINDICATES: "DO NOT WARM ISCHEMIC OR NON-PERFUSED TISSUE; THERMAL INJURY MAY RESULT. EXAMPLES INCLUDE TISSUE DISTAL TO AORTIC CROSS CLAMPING, OR WHEN VASOCONSTRICTIVE DRUGS WOULD LEAD TO SEVERE, PROLONGED VASOCONSTRICTION." IT IS CONCLUDED THAT PRODUCT MISUSE (VIA PINHOLES/CUTS IN THE SHELL) CAUSED THE WARMING MATTRESS TO NOT PERFORM TO SPECIFICATION. THE WARMING MATTRESS SHOULD NOT HAVE BEEN USED IN THIS PROCEDURE DUE TO BEING EXPIRED, DAMAGED, AND ALARMING.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE REPORTER: "LIPOSUCTION WITH FAT GRAFTING TO THE BUTTOCKS AND SPIRAL THIGH LIFT. THE PATIENT WAS PRONE FOR A FEW HOURS, ONCE THE PATIENT WAS FLIPPED, WE NOTICED THE BURN ON THE ANTERIOR ASPECT OF RIGHT THIGH." THE BURN IS ALLEGEDLY A MIXED 2ND/3RD DEGREE BURN COVERING APPROXIMATELY 10 SQ INCHES. A CONVERSATION WITH CLINICAL STAFF REVEALED THAT DURING THE PROCEDURE THE DEVICE ALARMED. A VASOCONSTRICTOR, USING TUMESCENT TECHNIQUE, WAS APPLIED TO THE THIGHS PRIOR TO LIPOSUCTION AND SKIN TIGHTENING WHILE THE PATIENT WAS IN SUPINE. THE PATIENT WAS THEN FLIPPED TO PRONE, AND THE TISSUE THAT HAD BEEN OPERATED ON WAS IN DIRECT CONTACT WITH THE WARMING MATTRESS FOR SEVERAL HOURS. PER AUGUSTINE'S INVESTIGATION: THE WARMING MATTRESS WAS TESTED ACCORDING TO COMPANY PROCEDURES AND WAS NOT PERFORMING TO SPECIFICATIONS. IT FAILED TEMPERATURE UNIFORMITY TESTS AND SHOWED SIGNS OF COOL SPOTS AND WARMER SPOTS. THE WARMER SPOTS WERE ISOLATED TO A FEW LOCATIONS ALONG THE EDGE OF THE MATTRESS (IN THE AREA THAT WOULD HAVE CONTACTED THE INJURY) AND MEASURED AT 46C. THE SENSORS WERE CONFIRMED TO BE WORKING PROPERLY. THE MATTRESS WAS PAST ITS LABELED EXPIRATION DATE. VISUAL INSPECTION OF THE MATTRESS FOUND EXTENSIVE DAMAGE TO THE UPPER SURFACE OF THE MATTRESS: APPROXIMATELY 183 PINHOLES/PUNCTURES WERE COUNTED ON THE UPPER SURFACE. CLEANING FLUID STAINS WERE OBSERVED UNDER MOST OF THE PIN HOLES, WHICH DEGRADED THE HEATER FABRIC, INCREASING THE RESISTANCE AT THOSE LOCATIONS. THE AREAS DAMAGED BY CLEANING FLUID INGRESS PREVENTED THE ELECTRICAL CURRENT (DC) FROM FLOWING ADEQUATELY FROM THE BUSS BAR TO BUSS BAR (THROUGH THE DAMAGED AREAS). THIS RESULTED IN MORE CURRENT DENSITY FLOWING THROUGH THE UNDAMAGED HEATER AREAS (ADJACENT TO THE HEATER DAMAGE), RESULTING IN AREAS WITH MEASURED TEMPERATURES HIGHER THAN SPECIFICATION ALLOWS. THE LOCATION OF THE BURN CORRELATES WITH THE WARMER SPOTS ON THE MATTRESS. ACCORDING TO TUT, THE HOTTEST LOCATION ON THE MATTRESS WAS 42.3°C. HOTSPOTS CLOSER TO THE EDGE OF THE MATTRESS IN THE IR IMAGE WERE MEASURED AT 46°C. ABSENT THE DAMAGE TO THE MATTRESS, THE INJURY WOULD NOT HAVE OCCURRED. THE SEMI-CONDUCTIVE POLYMER FABRIC HEATER HAS A LOW THERMAL STORAGE CAPACITY, LOW WATT DENSITY, AND IS A LOW HEAT-TRANSFER DEVICE. THEREFORE, DESPITE THE HIGHER TEMPERATURE READING, THE INJURY WOULD NOT HAVE OCCURRED EVEN WITH THE DAMAGE HAD THE TISSUE IN CONTACT WITH THAT AREA BEEN ADEQUATELY PERFUSED. SEE SECTION H11 FOR ADDITIONAL MANUFACTURER NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389919 HOTDOG UNDER BODY WARMING MATTRESS 127 CM ( 50") ELECTRIC HEATING PAD DWJ AUGUSTINE TEMPERATURE MANAGEMENT LLC U102 00855913001527

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention