BEUDAMED
    FDA Adverse Event Death Summary report: N

    SONICAID

    MDR report key: 6998569 · Received November 3, 2017

    Report

    Report Number
    1000589001-2017-00001
    Event Type
    Death
    Date Received
    November 3, 2017
    Date of Event
    August 28, 2017
    Report Date
    October 5, 2017
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012069 BY HUNTLEIGH HEALTHCARE, LTD (MANUFACTURER, REGISTRATION #1000589001) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (THE IMPORTER, REGISTRATION #1419652). BASED ON INFORMATION PROVIDED TO DATE, THIS INCIDENT OCCURRED ON THE (B)(6) 2017, IN WHICH A PREGNANT WOMAN WAS ADMITTED WITH SLIGHT BLEEDING PV ("METRORRHAGIA"). SHE WAS PLACED ON A TEAMDUO FETAL MONITOR, SERIAL NO. (B)(4) WHICH INCLUDES A TEAMCARE PRINTER MODULE, SERIAL NO. (B)(4). NO FURTHER CLINICAL INFORMATION HAS BEEN PROVIDED OTHER THAN A STATEMENT THAT THERE WERE NO DIRECT CLINICAL CONSEQUENCES IN THIS INCIDENT DUE TO THE FETAL MONITOR PROBLEM . THE STAFF REPORTED THAT THE FETAL MONITOR INDICATED A RATE OF 160BPM BUT THAT "THE NOISE PERCEIVED IN THE EAR WAS DIFFERENT FROM USUALLY. VALUES RECORDED AT 160BPM (OSCILLATING NOT" (SIC). THE ABSENCE OF FETAL CARDIAC ACTIVITY WAS CONFIRMED BY ULTRASOUND SCAN PERFORMED BY THE GYNAECOLOGIST WITHIN A FEW MINUTES FOLLOWING THIS TRACE. THE SCAN CONFIRMED FETAL DEATH. THE INCIDENT REPORT FURTHER DETAILS THAT, FOLLOWING CONFIRMATION OF FETAL DEATH, THE FETAL MONITOR WAS RE-APPLIED TO "COMPARE WITH WHAT WAS RECORDED: A RHYTHM AT 160 BPM IS ALWAYS HEARD BY THE MIDWIFE, THE STUDENT AND THE DOCTOR." A COPY OF THE TRACE CONCERNED HAS BEEN SUPPLIED, AND THE FETAL MONITOR HAS BEEN RETURNED TO US FOR EXAMINATION. INVESTIGATION: ON EXAMINATION, THE FOLLOWING OBSERVATIONS ARE NOTED: THIS FETAL MONITOR APPEARS TO BE A VERY OLD UNIT MANUFACTURED IN 2001 AND WAS THEREFORE NOT MANUFACTURED BY HUNTLEIGH, WHO DID NOT ACQUIRE THE OXFORD SONICAID BUSINESS UNTIL 2005. FROM THE TRACE, IT IS NOTED THAT THE BLUE TRANSDUCER WAS IN USE FOR SINGLETON MONITORING INSTEAD OF THE YELLOW ONE. THIS IS CONTRARY TO THE RECOMMENDATIONS FOR USE ON THIS PRODUCT, AS THE BLUE TRANSDUCER IS RECOMMENDED FOR USE ONLY AS THE SECOND ULTRASOUND TRANSDUCER WHEN MONITORING TWINS. WHEN TESTED, THIS BLUE TRANSDUCER EXHIBITED A HIGH NOISE LEVEL WHEN LOADED, AND LOOSE PARTS COULD BE HEARD RATTLING INSIDE THE TRANSDUCER BODY. ON DISASSEMBLY, IT WAS CONFIRMED THAT ONE OF THE PIEZO-CRYSTALS HAD BROKEN FREE OF THE FACEPLATE AND WAS LOOSE INSIDE. THIS IS MOST LIKELY TO HAVE BEEN CAUSED BY ABUSE (EG. DROPPING ON THE FLOOR). IN ADDITION TO A LOSS OF SENSITIVITY, THIS LOOSE COMPONENT COULD SHORT OUT OTHER COMPONENTS, WIRING CONNECTIONS, ETC., AT ANY TIME DEPENDING ON ITS POSITION IN THE HOUSING AND HAVE A SIGNIFICANT EFFECT ON PERFORMANCE. ON EXAMINATION OF THE TRACE ITSELF, THE FOLLOWING POINTS ARE NOTED: TRACE START TIME 12:21 ON THE (B)(6) 2017. THE "ULT -B" ANNOTATION INDICATES THAT THE BLUE SECONDARY TRANSDUCER WAS BEING USED AS THE ONLY, PRIMARY, TRANSDUCER. THE GESTATIONAL AGE WAS ENTERED AS (B)(6) CONFIRMING THIS TO BE A FULL TERM PREGNANCY, ASSUMING THE FETUS WAS ALIVE AT THIS TIME. THE TRACE COPY ENDS JUST AFTER 12:40 - IT IS NOT POSSIBLE TO DETERMINE FROM THE COPY SUPPLIED IF THIS IS WHERE THE LIVE TRACE ACTUALLY ENDED. THE TRACE PATTERN IS UNUSUAL, IN THAT THE PRINTED RATE APPEARS TO BE CENTRED AROUND A VERY STABLE "BASELINE" OF 160BPM, EXCEPT DURING BRIEF PERIODS OF ARTEFACT, POSSIBLY MATERNAL IN ORIGIN. IT IS NOT POSSIBLE TO DETERMINE WHETHER THIS TRACE PATTERN IS OF FETAL OR MATERNAL (DOUBLE RATED) ORIGIN, OR ONE DERIVED FROM NOISE, EITHER FROM WITHIN THE FETAL MONITOR (INCLUDING THE FAULTY US TDR) OR FROM EXTERNAL SOURCES (EG. MOBILE PHONE, CORDLESS PHONE, OTHER WIRELESS DEVICES OPERATING IN CLOSE PROXIMITY). HOWEVER, FROM THE DESCRIPTION OF THE UNUSUAL SOUND FROM THE ATTENDING CLINICAL STAFF, IT IS CONSIDERED PROBABLE THAT SUCH NOISE CONTRIBUTED TO THIS TRACE PATTERN. A HAND-WRITTEN ANNOTATION AT THE END OF THIS TRACE IS INTERPRETED AS BEING A REQUEST FOR A SCAN TO BE PERFORMED, PRESUMABLY TO CONFIRM FETAL LIFE. IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE REPORTED SITUATION OF AN UNUSUAL SOUND, OR OF THIS PRODUCING A TRACE AT, OR AROUND, 160BPM. IT IS CLEAR THAT THE TRANSDUCER FAULT WILL COMPROMISE THE PERFORMANCE OF THE PRODUCT. CONCLUSION & RECOMMENDATIONS: KEY POINTS RELATING TO THIS INCIDENT ARE SUMMARISED BELOW: THIS UNIT WAS NOT MANUFACTURED BY HUNTLEIGH. THIS UNIT WAS CLEARLY FAULTY ON INSPECTION (BLUE TRANSDUCER). THIS FAILURE IS MOST LIKELY TO BE DUE TO ABUSE. IT IS NOT POSSIBLE TO DETERMINE IF THIS FAILURE OCCURRED BEFORE, DURING, OR AFTER THE REPORTED INCIDENT. IT IS ALSO NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY WHETHER THIS FAULT MAY HAVE CONTRIBUTED TO A FALSE TRACE PATTERN BUT IT CANNOT BE EXCLUDED. IT IS ALSO POSSIBLE THAT EXTERNAL FACTORS (CLOSE PROXIMITY OF A MOBILE PHONE, WIRELESS DEVICE OR OTHER EXTERNAL, OR MAINS BORNE SOURCE OF INTERFERENCE) MAY EXPLAIN AN UNUSUAL SOUND AND TRACE PATTERN. THIS FETAL MONITOR IS OVER 15 YEARS OLD - IT IS CONSIDERED TO BE LONG PAST WHAT WE WOULD CONSIDER NORMAL FOR THE EXPECTED OPERATING LIFE OF A FETAL MONITOR AND WE WOULD NOT HAVE EXPECTED IT TO BE STILL IN CLINICAL USE. THE REPORT SUBMITTED TO (B)(6) CLEARLY STATED THAT THERE WAS NO CLINICAL CONSEQUENCE OF THIS EQUIPMENT PROBLEM AS AN ULTRASOUND SCAN WAS PERFORMED, CONFIRMING FETAL DEATH, WITH "[?]ONLY A DOUBT OF A FEW MINUTES[?]" IN CONCLUSION, WHILE IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE REPORTED UNUSUAL SOUND OR TRACE PATTERN ON THIS FETAL MONITOR, AND IT IS POSSIBLE THAT THE TRANSDUCER MAY HAVE BEEN FAULTY AT THE TIME THE MONITOR WAS USED, THE HOSPITAL REPORT CLEARLY STATES THAT THIS IN NO WAY CONTRIBUTED TO THE OUTCOME. HOWEVER, THIS FETAL MONITOR IS WAY BEYOND ANY REASONABLE EXPECTATION OF ITS OPERATING LIFE AND IT SHOULD NOT BE RETURNED TO CLINICAL USE. IT IS RECOMMENDED THAT IT IS SCRAPPED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN (B)(6) AND WAS REPORTED TO (B)(6), WHO REPORTED TO THE MANUFACTURER. PATIENT ARRIVED WITH SLIGHT METRORRHAGIA. FETAL HEART INDICATED ON THE MONITOR AT 160 BEATS PER MINUTE BUT THE NOISE PERCEIVED IN THE EAR WAS DIFFERENT TO USUAL. VALUES RECORDED AT 160 BEATS PER MINUTE. CONFIRMATION OF THE ABSCENCE OF CARDIAC ACTIVITY WITH 'ULTRASONOGRAPHY' AND BY THE GYNECOLOGIST. AFTER THE OBSERVATION OF THE DEATH, THE MONITOR IS CONNECTED ANOTHER TIME ON THE PATIENT TO COMPARE WITH WHAT WAS RECORDED; A RHYTHM AT 160 BEATS PER MINUTE IS ALWAYS HEARD BY THE MIDWIFE, THE STUDENT AND THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780519 SONICAID PERINATAL MONITORING SYSTEM AND ACCESSORIES HGM HUNTLEIGH HEALTHCARE LTD TEAMDUO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O