BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICAID

    MDR report key: 5441339 · Received February 17, 2016

    Report

    Report Number
    1000589001-2016-00001
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    November 29, 2015
    Report Date
    February 17, 2016
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD
    Product Code
    HGM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012069 BY HUNTLEIGH HEALTHCARE LTD (REGISTRATION #1000589001) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #1419652). REPORT ON FINDINGS: WITH KNOWLEDGE OF THE DESIGN IT IS DETERMINED THAT NOISE COULD HAVE BEEN GENERATED BY THE FAULTY TDR AND AS A RESULT THE METER/DISPLAY COULD HAVE PRODUCED A "FLAT LINE" TRACE. ALTHOUGH, WITHOUT CERTAIN EVIDENCE AND FACTS, THIS REPORT CANNOT CONCLUDE WITH A ROOT CAUSE. WHAT IS MEANT BY "FLAT LINE" IS THAT WE WOULD NOT EXPECT THIS TO BE A RULER-STRAIGHT LINE, BUT AN INTERMITTENT LINE WITH A LEVEL OF DROPOUT AND A LEVEL OF NOISE SUPERIMPOSED. WE WOULD ALSO EXPECT THIS TO REFLECT IN AUDIBLE INTERFERENCE WHICH WOULD CLEARLY SOUND ABNORMAL & WE WOULD NOT EXPECT THIS TO BE READILY MISTAKEN FOR TRUE PHYSIOLOGICAL SOUNDS. WE CANNOT COMMENT FURTHER AS TO THE CLINICAL SITUATION & THE DECISION TO PERFORM A CAESAREAN SECTION WITHOUT SEEING THE TRACE CONCERNED & FURTHER INFORMATION THAN HAS BEEN SUPPLIED, CONCERNING THE CLINICAL SCENARIO - EG. GESTATIONAL AGE, CLINICAL HISTORY, INDICATIONS FOR MONITORING, WHETHER THE MOTHER WAS IN LABOUR OR NOT, THE LENGTH OF THE TRACE ON WHICH THE CLINICAL DECISION WAS MADE, ANY PREVIOUS TRACES, WHAT OTHER TESTS WERE PERFORMED, ETC. ACCORDING TO OUR SERVICE DATABASE THIS MONITOR WAS SOLD 02/08/2001 MAKING IT 15 YEARS OLD. THIS UNIT WAS RETURNED TO HUNTLEIGH FOR REPAIR ONCE IN OCTOBER 2008 WITH A DAMAGED SPO2 CABLE ASSEMBLY AND NOT RELATED TO THIS INCIDENT. IT IS ALSO CONFIRMED THAT THERE IS NO MAINTENANCE PROGRAMME IN PLACE FOR THE HOSPITAL IN QUESTION. NO OTHER SERVICE REPORTS HAVE BEEN LOGGED FOR THE UNIT IN QUESTION. (B)(4). REVIEW OF TRACES: NO TRACES WERE PRESENTED. CONCLUSION: WITH THE LIMITED INFORMATION AVAILABLE (UNIT NOT MANUFACTURED BY HUNTLEIGH (B)(4)) AND THE AGE OF THE UNIT IN QUESTION, NO ACCURATE CONFIRMATION CAN BE MADE AS TO THE ROOT CAUSE OF THE DECISION TO CONDUCT A C-SECTION. WHAT IS CLEAR THOUGH IS THAT THE CLINICAL PROTOCOL (REFER TO ALTERNATIVE METHODS PRIOR TO TAKING MEDICAL ACTION) HAS NOT BEEN FOLLOWED. RISK ASSESSMENT: WITH THE INFORMATION PROVIDED THE RISK MANAGEMENT FILE HAS BEEN REVIEWED AND CONCLUDED THAT THE MITIGATION OF THE ASSOCIATED RISKS HAVE BEEN ADEQUATELY DOCUMENTED AND ARE ACCEPTABLE, I.E., WARNINGS HAVE BEEN INCLUDED IN RELEVANT AREAS. HOWEVER WE CANNOT STATE THE PROBLEM WILL NOT REOCCUR AS FURTHER MITIGATION OF THESE RISKS IS OUTSIDE OUR DIRECT CONTROL, BEING DRIVEN BY LOCAL & NATIONAL GUIDELINES, PROTOCOLS, TRAINING & INDIVIDUAL CLINICIAN'S PRACTICES. WHILE APPROPRIATE MESSAGES ARE AVAILABLE TO THE USER (IFU AND TRACE), THERE IS A LIKELIHOOD OF RECURRENCE OF THESE SORTS OF INCIDENTS IF THESE MESSAGES ARE NOT ACTED ON APPROPRIATELY AND IF OTHER CLINICAL SIGNS ARE IGNORED. NO SIMILAR ISSUE HAS BEEN REPORTED. CORRECTIVE / PREVENTATIVE ACTIONS, INCLUDING FIELD SAFETY CORRECTIVE ACTIONS: NONE REQUIRED.

    Description of Event or Problem · 0

    HEART RATE READING ABOUT 110BPM. THERE WAS INTERFERENCE CAUSING THE METER TO GIVE AN ABNORMAL READING. INCORRECT FETAL HEART RATE INFORMED WRONG DIAGNOSIS LEADING TO AN UNNECESSARY CAESAREAN SECTION PROCEDURE. BABY AND MOTHER WERE HEALTHY POST OPERATION. THE FAULT OF THE INTERFERENCE WAS FOUND WITH THE YELLOW 1.5MHZ ULTRASOUND TRANSDUCER WHICH HAD A NON VISABLE CABLE BREAK CAUSING A LOT OF INTERFERENCE TO BE PICKED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97736 SONICAID FM830 ADAPT HGM HUNTLEIGH HEALTHCARE LTD FM830

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability