BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON TOCO MP TRANSDUCER

    MDR report key: 24198408 · Received January 28, 2026

    Report

    Report Number
    9610816-2026-100153
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    December 25, 2025
    Report Date
    February 19, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    UDI-DI
    00884838021471
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS REMOTE SERVICE ENGINEER (RSE) CONTACTED THE CUSTOMER BIOMED. THE BIOMED STATED THAT HE IS NOT IN A POSITION TO GIVE MORE INFORMATION ABOUT THIS EVENT OTHER THAN THE TRANSDUCER MEMBRANE WAS SPLIT AND THE DEVICE WAS EXCHANGED WITH ANOTHER ONE. THE NATURE OF THE SHOCK WAS NOT PROVIDED. THE RSE HAS REACHED OUT TO THE NURSE CHIEF SEVERAL TIMES, BUT THERE HAS BEEN NO RESPONSE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    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. REPORTING INSTITUTION PHONE # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NURSE RECEIVED AN ELECTRIC SHOCK FROM THE TRANSDUCER. IT WAS NOTED THE MEMBRANE ON THE TRANSDUCER WAS SPLIT, SO IT WAS EXCHANGED. THE NATURE OF THE SHOCK WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263693 AVALON TOCO MP TRANSDUCER MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) HFM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON TOCO MP TRANSDUCER 00884838021471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other