BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 20733739 · Received November 20, 2024

    Report

    Report Number
    9610816-2024-000863
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    January 6, 2024
    Report Date
    January 28, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    UDI-DI
    00884838000414
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - THIS EVENT OCCURRED OVER 4 MONTHS IN 2024, WITH 30 MONITORS, AN EXACT EVENT DATE COULD NOT BE ESTABLISHED PATIENT INVOLVEMENT WAS REPORTED, IT WAS REPORTED THAT NO INCIDENTS ENDANGERING PATIENT SAFETY HAVE OCCURRED FOLLOWING THE NST RESULT. PHILIPS FIELD SUPPORT ENGINEERS (FSE'S) HAVE ATTENDED THE SITE TO INVESTIGATE WHETHER THE KIT IS FAULTY AND HAVE CONFIRMED THAT IT IS NOT FAULTY. CLINICAL APPLICATION SPECIALIST (CAS) HAVE ALSO ATTENDED THE SITE TO REFRESH TRAINING AND ENSURE THAT THE ISSUES ARE NOT DUE TO STAFF INCOMPETENCE'S. THE CAS DID REPORT THAT THE STAFF WERE CAPABLE, HOWEVER THEY WERE NOT ABLE TO REPLICATE SOME OF THE REPORTED ISSUES. THE PRODUCT MANAGER, CLINICAL PRODUCT SPECIALIST AND THE RESEARCH AND DEVELOPMENT (R&D) TEAM HAVE INVESTIGATED ALL OF THE CLAIMS PROVIDED AND PROVIDED FEEDBACK TO THE CUSTOMER. THIS INVESTIGATION ESTABLISHED THAT THE NST ANALYSIS WAS PERFORMING AS DESIGNED AND IN LINE WITH THE ALGORITHM BUILD FROM THE 2002 DAWES & REDMAN PAPER. IT WAS CONCLUDED THAT ALL OF THE REPORTED ISSUES WERE ACTUALLY THE DAWES & REDMAN ALGORITHM GIVING RESULTS EXACTLY IN LINE WITH THE PUBLISHED CRITERIA IN THE 2002 PAPER. THE PRODUCT MANAGER, CLINICAL PRODUCT SPECIALIST AND R&D HAVE PROPOSED BOTH SHORT TERM AND LONG TERM SOLUTIONS TO THE CUSTOMER, BUT THE CUSTOMER HAS NOT ACCEPTED EITHER OF THESE SOLUTIONS YET AND THEY HAVE NOT RESPONDED TO COMMUNICATIONS SINCE THESE SOLUTIONS WERE PROPOSED TO THEM IN OCTOBER OF 2024.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER CLINICAL REVIEW, THIS CASE WAS DETERMINED NOT TO BE REPORTABLE DUE TO THE FOLLOWING RATIONALE: A FETAL NON-STRESS TEST (NST) IS A DIAGNOSTIC TOOL USED TO ASSESS FETAL WELL-BEING DURING THE ANTEPARTUM PHASE OF PREGNANCY, AND NOT DURING ACTIVE LABOR. THE NST REPORT IS A DIAGNOSTIC AID AND SHOULD BE USED IN CONJUNCTION WITH A CLINICIAN¿S INTERPRETATION, WHICH WOULD DRIVE ANY FURTHER TESTING OR CLINICAL RESPONSE. THE NST ALGORITHM IS BASED ON THE PUBLISHED GUIDANCE/ALGORITHM PROVIDED UNDER DAWES-REDMAN. IT WAS DETERMINED THE REPORTED ISSUES WERE FOUND TO BE WITHIN THE DAWES-REDMAN ALGORITHM, GIVING RESULTS IN LINE WITH THE PUBLISHED CRITERIA, AND NOT INACCURATE. THOUGH THE CUSTOMER MIDWIVES DISAGREED WITH SOME RESULTS, IT WAS DETERMINED THEY WERE DISAGREEING MORE WITH THE GUIDANCE PUBLISHED WITHIN DAWES-REDMAN AND DESIRED A POTENTIAL ENHANCEMENT TO THE ALGORITHM, WHICH IS NOT SUPPORTED BY THE DEVICE AT THIS TIME. IN ADDITION, THERE WAS NO PATIENT HARM. BASED ON THIS INFORMATION, THERE WAS NO PATIENT HARM AND NO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. CUSTOMER INDICATED THIS HAS OCCURRED WITH 30 DEVICES. SERIAL NUMBERS OF THESE DEVICES ARE CURRENTLY UNKNOWN. THE DATES OF THE EVENTS ARE CURRENTLY UNKNOWN AS WELL REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A USER REPORT THAT THE MONITOR'S NON-STRESS TEST (NST) PRODUCED REPORTS THAT ARE INACCURATE. THE DEVICE INACCURACIES WERE AS DESCRIBED AS FOLLOWS: NST CRITERIA MET REPORTS ARE OUTSIDE THE GUIDELINES AND DO NOT MEET ALL ALGORITHM CRITERIA, PRODUCES REPORTS OVER THE CUT OFF PERCENTAGE OF SIGNAL LOSS, REPETITIVE DECELERATIONS MET, AND REPORTS NOT REPRESENTATIVE OF VISUAL RECORDING. BASED ON THE LIMITED INFORMATION RECEIVED, THERE WAS NO INDICATION THE REPORTED ISSUES CAUSED OR CONTRIBUTED TO ANY PATIENT HARM. AS THE INFORMATION PROVIDED DID NOT PROVIDE SPECIFICS OR ANY PATIENT IMPACT, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070097 AVALON FM30 FETAL MONITOR AVALON FM30 FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M2703A 00884838000414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female