BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FM30 FETAL MONITOR

    MDR report key: 16938884 · Received May 16, 2023

    Report

    Report Number
    9610816-2023-00232
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    March 27, 2023
    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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BENCH REPAIR TECHNICIAN (BRT) FOUND THAT THERE WAS A CONSTANT REPEATED FETAL HEART FREQUENCY (FHF) DEVICE ERROR IN THE ALARM OVERVIEW. THE BRT DETERMINED THAT THE FHF DEVICE ERROR WAS PRODUCED BY A DEFECTIVE CONNECTED ULTRASOUND SENSOR. THE CAUSE OF THE REPORTED LOUDSPEAKER PROBLEM WAS THE DEFECTIVE CONNECTED ULTRASOUND SENSOR. THE THIRD-PARTY SERVICE ENGINEER PROVIDED THEIR ANALYSIS FINDINGS THAT THE SENSOR WAS DEFECTIVE.

    Additional Manufacturer Narrative · 0

    THE DIAGNOSTIC/FUNCTIONAL TESTING WAS PERFORMED AT THE PHILIPS AUTHORIZED REPAIR FACILITY. FUNCTIONAL TESTING INDICATES THAT IN THE ALARM OVERVIEW, THERE WAS A CONSTANT REPEATED FETAL HEART FREQUENCY (FHF) DEVICE ERROR. THE FHR ERROR WAS PRODUCED BY A DEFECTIVE CONNECTED ULTRASOUND SENSOR. THE CAUSE OF THE REPORTED PROBLEM (LOUDSPEAKER FAILURE) WAS UNKNOWN AFTER RECEIVING NO ADDITIONAL INFORMATION FROM A GFE REGARDING THE CAUSE. THE REPORTED PROBLEM WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AVALON FM30 FETAL MONITOR INDICATING THAT THERE WAS A LOUDSPEAKER FAILURE. A GOOD FAITH EFFORT (GFE) WAS MADE TO DETERMINE WHETHER THE SPEAKER PRODUCED SOUND, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637900 AVALON FM30 FETAL MONITOR AVALON FM30 FETAL MONITOR HGM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M2703A 00884838000414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown