BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 20319702 · Received September 27, 2024

    Report

    Report Number
    9610816-2024-00631
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 20, 2024
    Report Date
    December 9, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED THERE WAS NO HARM TO THE PATIENT AS THE USER CONTINUED TO USE A DOPPLER TO ASSESS HEART TONES AND THE BABY WAS DELIVERED WITHIN 10 MINUTES OF HEARING THE FIRST DECELERATION. THE CUSTOMER INDICATED THEY BELIEVE WHEN THE MONITOR IS MOVED IN VARIOUS POSITIONS, IT PUTS STRAIN ON THE RIBBON CABLE AND THE ONLY RESOLUTION IS REPLACEMENT OF THE RIBBON CABLE. IN ADDITION, THE CUSTOMER ALSO INDICATED THE STAFF FOLLOWED CORRECT PROTOCOL WHEN THE FETAL MONITOR FAILED AND THE USERS CONTINUED TO USE DOPPLER TO MONITOR THE FETAL HEART RATE. THE CUSTOMER STATED THEY WERE ABLE TO SOLVE THE DISPLAY ISSUE THEMSELVES AFTER THE EVENT. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. AS IT WAS CONFIRMED THERE WAS NO PATIENT OR USER HARM, THIS REPORT NO LONGER MEETS THE CRITERIA FOR A REPORTABLE EVENT. A FLICKERING SCREEN WOULD BE OBVIOUS TO THE USER UNDER CLOSE PERSONAL SURVEILLANCE AS DESCRIBED IN THE PRODUCT LABELING SHIPPED WITH THE DEVICE. THE DEVICE IS ALSO DESIGNED TO EMIT A BEEP AT THE TIME OF REBOOT IN CASE THE FLICKERING SCREEN IS COMBINED WITH A REBOOT. IN THE CASE WHERE ISP/OBTV IS ALSO AVAILABLE, THE MONITORING OF PARAMETERS WILL CONTINUE TO BE DISPLAYED AT THE CENTRAL MONITOR, AND ON THE MONITOR THE USER WILL NOTICE PERIODIC PARAMETERS WHICH WILL BE DISPLAYED EVERY FEW SECONDS.

    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. A SECOND SERIAL NUMBER WAS REPORTED FOR THIS EVENT. AVALON FM30 FETAL MONITOR, CATALOG # M2703A, SERIAL # (B)(6) IS REPORTED IN MANUFACTURER'S REFERENCE 5182102. THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE, THE MONITOR WAS FULLY FUNCTIONAL; HOWEVER, WHEN CONNECTED TO THE PATIENT DUE TO HEART RATE DECELERATIONS NOTED DURING ACTIVE LABOR, THE FETAL MONITOR SCREEN TURNED ON AND OFF AND WAS BLURRY AND FUZZY. THIS WAS ALSO TRUE OF THE MOBILE FETAL MONITOR. GOOD FAITH EFFORTS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709971 AVALON FM30 FETAL MONITOR AVALON FM30 FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M2703A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other