BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 17043596 · Received June 1, 2023

    Report

    Report Number
    1220063-2023-00017
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    April 27, 2023
    Report Date
    October 23, 2023
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K203088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED BEHAVIOR HAS BEEN ANALYZED ON THE BASE OF THE PROVIDED VIDEOS. THE ANESTHESIA WORKSTATION HAS WEIGHT AND AGE LIMITS FOR THE THREE PATIENT CATEGORIES (NEONATE, PEDIATRIC, ADULT) BECAUSE THIS IS IMPORTANT TO CALCULATE DOSAGE FORECAST OF VOLATILE ANESTHETICS FOR THE INDIVIDUAL PATIENT. THE IACS DOESN'T HAVE THESE FIXED BOUNDARIES FOR THE PATIENT CATEGORIES BECAUSE THERE IS NO CLINICAL NEED FOR THAT. IN THE FIRST EXAMPLE GIVEN IN THE DESCRIPTION OF EVENT, IT COULD BE DETERMINED THAT THE PATIENT CATEGORY WAS NOT SET MANUALLY AT THE IACS AS INTENDED, IN SUCH CASE THE CONNECTIVITY CONVERTER CC300 IS DESIGNED TO USE THE PREVIOUSLY RECEIVED PATIENT CATEGORY AND TRANSMIT IT TO THE ANESTHESIA WORKSTATION. THE IACS SETTING WAS MADE TO AN AGE OF 4 YEARS AND A WEIGHT OF 20KG. BUT WITH NO PATIENT CATEGORY BEING PROVIDED, THE CC300 USED THE PREVIOUS INFORMATION "NEONATE"; THE RECEIVED DATA OF 4 YEARS AND 20KG WAS THEN REDUCED TO THE UPPER LIMIT OF THE VALUES FOR THAT PATIENT CATEGORY, 24 MONTHS AND 10KG. A SIMILAR EXPLANATION APPLIES FOR THE SECOND AND THIRD EXAMPLE: #2: IACS DATA WAS AT "NEONATE, 4 YEARS, 20KG" - WHEN THE PERSEUS RECEIVED THE PATIENT CATEGORY "NEONATE", IT CHANGED THE WEIGHT UNIT TO GRAMS PER DESIGN. THE AGE WAS REDUCED FROM 4 YEARS TO THE UPER LIMIT 24 MONTHS FOR THIS PATIENT CATEGORY AND, THE INPUT OF "20" FOR THE WEIGHT WAS INTERPRETED AS "20 GRAMS" AND THUS, THE SETTING WAS ADAPTED TO THE LOWER LIMIT OF THIS PATIENT CATEGORY, 0.4KG. IN EXAMPLE NUMBER 3, THE IACS DATA WAS SET TO "ADULT, 4 YEARS, 20KG". AFTER RECEIPT OF THE PATIENT CATEGORY "ADULT" THE PERSEUS HAS SET AGE AND WEIGHT TO THE LOWER LIMIT FOR THIS PATIENT CATEGORY, 12Y AND 30KG. DRÄGER FINALLY CONCLUDES THAT THE PERSEUS BEHAVED AS SPECIFIED. THE DESIGN WAS FIXED AFTER INTENSIVE USABILITY TESTING AND A DEDICATED RISK ASSESSMENT; POST MARKET SURVEILLANCE DATA REASONABLY CONFIRMS THAT THIS IS SAFE TO USE; THE DATA ADAPTATION IS MADE IN A LIMITED RANGE ONLY. FURTHERMORE, THE TRANSMITTED DATA IS SEEN AS A SUGGESTION AND MUST BE CONFIRMED BY THE USER IN AN EXTRA STEP - IT IS UNDER RESPONSIBILITY AND CONTROL OF THE USER TO MAKE SURE THAT APPROPRIATE SETTINGS ARE USED FOR THE INDIVIDUAL PATIENT. AS REPORTED FOR THIS CASE, AN UNINTENDED DIVERGENCE WILL BE RECOGNIZED BY THE USER AND CAN BE CORRECTED. A PATIENT MAY ONLY BE PUT AT RISK IF ANOTHER USE ERROR COMES INTO EFFECT (INCORRECT DATA ACCEPTED); THE PROBABILITY FOR SUCH SCENARIO IS CONSIDERED REMOTE.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT DATA WAS IMPORTED FROM THE *INFINITY ACUTE CARE SYSTEM (IACS) TO THE PERSEUS ANESTHESIA MACHINE VIA THE CC300 CONNECTIVITY CONVERTER. SPECIFICALLY, THE PATIENT CATEGORY, AGE AND WEIGHT ARE DISPLAYED CORRECTLY AT THE IACS COCKPIT BUT THE VALUES RECEIVED AND DISPLAYED AT THE PERSEUS ARE INCORRECT. THE ANESTHETIST CORRECTED THE INFORMATION MANUALLY ON THE PERSEUS. NO ADVERSE PATIENT IMPACT WAS REPORTED. VALUES FROM 3 DATA IMPORT ATTEMPTS (PATIENT CATEGORY / AGE / WEIGHT): FROM COCKPIT: PEDIATRIC / 4 YEARS / 20KG AT PERSEUS: NEONATE / 24 MO. / 10KG FROM COCKPIT: NEONATE / 4 YEARS / 20KG AT PERSEUS: NEONATE / 24 MO. / 0.4KG FROM COCKPIT: ADULT / 4 YEARS / 20KG AT PERSEUS: ADULT / 12 YEARS / 30KG *THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT DATA WAS IMPORTED FROM THE *INFINITY ACUTE CARE SYSTEM (IACS) TO THE PERSEUS ANESTHESIA MACHINE VIA THE CC300 CONNECTIVITY CONVERTER. SPECIFICALLY, THE PATIENT CATEGORY, AGE AND WEIGHT ARE DISPLAYED CORRECTLY AT THE IACS COCKPIT BUT THE VALUES RECEIVED AND DISPLAYED AT THE PERSEUS ARE INCORRECT. THE ANESTHETIST CORRECTED THE INFORMATION MANUALLY ON THE PERSEUS. NO ADVERSE PATIENT IMPACT WAS REPORTED. VALUES FROM 3 DATA IMPORT ATTEMPTS (PATIENT CATEGORY / AGE / WEIGHT): FROM COCKPIT: PEDIATRIC / 4 YEARS / 20KG. AT PERSEUS: NEONATE / 24 MO. / 10KG. FROM COCKPIT: NEONATE / 4 YEARS / 20KG. AT PERSEUS: NEONATE / 24 MO. / 0.4KG. FROM COCKPIT: ADULT / 4 YEARS / 20KG. AT PERSEUS: ADULT / 12 YEARS / 30KG. *THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31504 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown