BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHASTAR PRO, EU, SFC, LOW

    MDR report key: 20987024 · Received December 20, 2024

    Report

    Report Number
    8010652-2024-0000108
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 29, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113222B0 ALPHASTAR PRO, EU, SFC, LOW. AS IT WAS STATED, THE FOLLOWING COURSE OF EVENTS OCCURRED. THE INSTALLATION OF THE PATIENT IN THE GYNECOLOGICAL POSITION FOR RESECTION OF CERVICAL CONDYLOMAS AND DISINFECTION OF THE SURGICAL SITE WITH DAKIN WAS PERFORMED. A SINGLE-USE ABSORBENT PAD (ABSORBEX - NOT MANUFACTURED BY GETINGE) WAS PLACED UNDER THE PATIENT¿S BUTTOCKS FOR PROTECTION. THE OPERATION TOOK PLACE WITHOUT ISSUES UNTIL A BURNING SMELL WAS RELEASED IN THE OPERATING ROOM, FOLLOWED BY THE APPEARANCE OF FIRE AT THE ABSORBEX LEVEL. ACCORDING TO THE PROVIDED INFORMATION, THE LASER TARGETING THE CUSHION CAUSED THE HOLE IN IT AND AN INCREASE IN TEMPERATURE ON THE SURFACE OF THE CUSHION RESULTED IN A THIRD-DEGREE BURN OF THE PATIENT'S RIGHT BUTTOCK WITHOUT GENITAL DAMAGE. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE PATIENT. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. THE BIOMEDICAL ENGINEER AT THE CUSTOMER SITE EVALUATED THE PAD (90930693) AND PROVIDED PHOTOGRAPHIC EVIDENCE OF THE STATE OF THE AFFECTED DEVICE. THE PAD WAS CUT OPEN AND CONFIRMED TO HAVE NO BURN MARKS BEYOND THE SURFACE. THE FOAM INSIDE THE CUSHION WAS INTACT. ACCORDING TO THE HYPOTHESIS PROVIDED BY THE CUSTOMER, THE LASER CREATED A HOT SPOT ON THE ABSORBEX, WHICH CAUGHT FIRE IN ONE SPOT. GIVEN THE TIME IT TOOK THE TEAM TO EXTINGUISH THE FIRE, THE ABSORBEX HAD ENOUGH TIME TO BURN THE PATIENT AND PART OF THE PAD. THE TECHNICAL SUPPORT WAS CONTACTED AND CONFIRMED THAT THE MENTIONED PAD HAS A CERTAIN LEVEL OF FIRE RESISTANCE BUT IS NOT FLAME RETARDANT. BASED ON ALL THE PROVIDED INFORMATION AND THE PHOTOGRAPHIC EVIDENCE, IT HAS BEEN CONCLUDED THAT THE INCIDENT WAS CAUSED BY A USER ERROR IN HANDLING THE LASER, WHICH CONSEQUENTLY RESULTED IN THE ABSORBEX CATCHING FIRE. IT HAS BEEN RULED OUT THAT THE 113222B0 ALPHASTAR CONTRIBUTED TO THE REPORTED INCIDENT. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF B1 ADVERSE EVENT / PRODUCT PROBLEM, B3 DATE OF EVENT, B5 DESCRIBE EVENT OR PROBLEM, D4 SERIAL #, E1A INITIAL REPORTER, H3B DEVICE NOT EVAL PROVIDE CODE AND H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT & PRODUCT PROBLEM CORRECTED B1 ADVERSE EVENT / PRODUCT PROBLEM: ADVERSE EVENT. PREVIOUS B3 DATE OF EVENT: 12/05/2024. CORRECTED B3 DATE OF EVENT: 11/29/2024. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113222B0 ALPHASTAR PRO, EU, SFC, LOW. AS IT WAS STATED, THE FOLLOWING COURSE OF EVENTS OCCURRED. THE INSTALLATION OF THE PATIENT IN THE GYNECOLOGICAL POSITION FOR RESECTION OF CERVICAL CONDYLOMAS AND DISINFECTION OF THE SURGICAL SITE WITH DAKIN WAS PERFORMED. A SINGLE-USE ABSORBENT PAD (ABSORBEX) WAS PLACED UNDER THE PATIENT¿S BUTTOCKS FOR PROTECTION. THE OPERATION TOOK PLACE WITHOUT ISSUES UNTIL A BURNING SMELL WAS RELEASED IN THE OPERATING ROOM FOLLOWED BY THE APPEARANCE OF FIRE AT THE ABSORBEX LEVEL. ACCORDING TO THE PROVIDED INFORMATION, THE LASER TARGETING THE CUSHION CAUSED THE HOLE IN IT AND AN INCREASE IN TEMPERATURE ON THE SURFACE OF THE CUSHION RESULTED IN A THIRD-DEGREE BURN OF THE PATIENT'S RIGHT BUTTOCK WITHOUT GENITAL DAMAGE. IT WAS CONFIRMED THAT THE PAD WAS BURNED ONLY ON ONE SIDE ON THE SURFACE. THE FOAM INSIDE THE CUSHION WAS NOT BURNED. WE DECIDED TO REPORT THE ISSUE DUE TO SERIOUS INJURY OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113222B0 ALPHASTAR PRO, EU, SFC, LOW. AS IT WAS STATED, THE FOLLOWING COURSE OF EVENTS OCCURRED. THE INSTALLATION OF THE PATIENT IN THE GYNECOLOGICAL POSITION FOR RESECTION OF CERVICAL CONDYLOMAS AND DISINFECTION OF THE SURGICAL SITE WITH DAKIN WAS PERFORMED. A SINGLE-USE ABSORBENT PAD (ABSORBEX - NOT MANUFACTURED BY GETINGE) WAS PLACED UNDER THE PATIENT¿S BUTTOCKS FOR PROTECTION. THE OPERATION TOOK PLACE WITHOUT ISSUES UNTIL A BURNING SMELL WAS RELEASED IN THE OPERATING ROOM, FOLLOWED BY THE APPEARANCE OF FIRE AT THE ABSORBEX LEVEL. ACCORDING TO THE PROVIDED INFORMATION, THE LASER TARGETING THE CUSHION CAUSED THE HOLE IN IT AND AN INCREASE IN TEMPERATURE ON THE SURFACE OF THE CUSHION RESULTED IN A THIRD-DEGREE BURN OF THE PATIENT'S RIGHT BUTTOCK WITHOUT GENITAL DAMAGE. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE PATIENT. PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: (B)(6). PREVIOUS E1A INITIAL REPORTER: (B)(6). CORRECTED E1A INITIAL REPORTER: (B)(6). PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: USE OF DEVICE PROBLEM///1670. ENVIRONMENTAL COMPATIBILITY PROBLEM/AMBIENT TEMPERATURE PROBLEM//2878. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM///2993.

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: (B)(6). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE (B)(6) 2022. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113222B0 ALPHASTAR PRO, EU, SFC, LOW. AS IT WAS STATED, THE FOLLOWING COURSE OF EVENTS OCCURRED. THE INSTALLATION OF THE PATIENT IN THE GYNECOLOGICAL POSITION FOR RESECTION OF CERVICAL CONDYLOMAS AND DISINFECTION OF THE SURGICAL SITE WITH DAKIN WAS PERFORMED. A SINGLE-USE ABSORBENT PAD (ABSORBEX - NOT MANUFACTURED BY GETINGE) WAS PLACED UNDER THE PATIENT¿S BUTTOCKS FOR PROTECTION. THE OPERATION TOOK PLACE WITHOUT ISSUES UNTIL A BURNING SMELL WAS RELEASED IN THE OPERATING ROOM, FOLLOWED BY THE APPEARANCE OF FIRE AT THE ABSORBEX LEVEL. ACCORDING TO THE PROVIDED INFORMATION, THE LASER TARGETING THE CUSHION CAUSED THE HOLE IN IT AND AN INCREASE IN TEMPERATURE ON THE SURFACE OF THE CUSHION RESULTED IN A THIRD-DEGREE BURN OF THE PATIENT'S RIGHT BUTTOCK WITHOUT GENITAL DAMAGE. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE PATIENT.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113222B0 ALPHASTAR PRO, EU, SFC, LOW. AS IT WAS STATED, THE FOLLOWING COURSE OF EVENTS OCCURRED. THE INSTALLATION OF THE PATIENT IN THE GYNECOLOGICAL POSITION FOR RESECTION OF CERVICAL CONDYLOMAS AND DISINFECTION OF THE SURGICAL SITE WITH DAKIN WAS PERFORMED. A SINGLE-USE ABSORBENT PAD (ABSORBEX) WAS PLACED UNDER THE PATIENT¿S BUTTOCKS FOR PROTECTION. THE OPERATION TOOK PLACE WITHOUT ISSUES UNTIL A BURNING SMELL WAS RELEASED IN THE OPERATING ROOM FOLLOWED BY THE APPEARANCE OF FIRE AT THE ABSORBEX LEVEL. ACCORDING TO THE PROVIDED INFORMATION, THE LASER TARGETING THE CUSHION CAUSED THE HOLE IN IT AND AN INCREASE IN TEMPERATURE ON THE SURFACE OF THE CUSHION RESULTED IN A THIRD-DEGREE BURN OF THE PATIENT'S RIGHT BUTTOCK WITHOUT GENITAL DAMAGE. IT WAS CONFIRMED THAT THE PAD WAS BURNED ONLY ON ONE SIDE ON THE SURFACE. THE FOAM INSIDE THE CUSHION WAS NOT BURNED. WE DECIDED TO REPORT THE ISSUE DUE TO SERIOUS INJURY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146732 ALPHASTAR PRO, EU, SFC, LOW TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 113222B0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ABSORBEX (NOT MANUFACTURED BY GETINGE).