BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON CABLELESS TOCO+ MP TRANSDUCER

    MDR report key: 23349560 · Received October 21, 2025

    Report

    Report Number
    9610816-2025-000981
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 19, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    UDI-DI
    00884838034235
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER INVESTIGATION THIS COMPLAINT IS DEEMED NOT A REPORTABLE EVENT WITH PHILIPS. PHYSICAL DAMAGE OR A DEFECT OF THE DEVICE WOULD BE OBVIOUS TO THE USER WHEN MONITORING UNDER CLOSE PERSONAL SURVEILLANCE, AS DESCRIBED IN THE PRODUCT LABELING SHIPPED WITH THE DEVICE. THIS WOULD PROMPT THE USER TO USE ALTERNATIVE METHODS OF MONITORING OR TO TROUBLESHOOT THE DEVICE. PRODUCT LABELING INSTRUCTS USERS TO PERFORM A VISUAL INSPECTION BEFORE EACH USE, AND IN ACCORDANCE WITH THE HOSPITAL'S POLICY INCLUDING INSPECTION OF ALL ACCESSORIES (TRANSDUCERS, SENSORS AND CABLES). USERS ARE INSTRUCTED TO NOT USE A DAMAGED ACCESSORY. EXAMINE ALL SYSTEM CABLES, THE POWER PLUG AND CORD FOR DAMAGE. MAKE SURE THAT THE PRONGS OF THE PLUG DO NOT MOVE IN THE CASING. IF DAMAGED, REPLACE IT WITH AN APPROPRIATE POWER CORD. INSPECT THE CABLES, LEADS AND THEIR STRAIN RELIEFS FOR GENERAL CONDITION. MAKE SURE THERE ARE NO BREAKS IN THE INSULATION. MAKE SURE THAT THE CONNECTORS ARE PROPERLY ENGAGED AT EACH END TO PREVENT ROTATION OR OTHER STRAIN. THEREFORE DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE TRANSDUCERS ARE CRUMBLING WHEN CLEANED WITH OXIVIR EXCEL WIPES. THIS REPORTED ISSUE IS OCCURRING AT SEVERAL CUSTOMER HOSPITAL SITES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS.

    Description of Event or Problem · 0

    THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000280 AVALON CABLELESS TOCO+ MP TRANSDUCER MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) HFM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CABLELESS TOCO+ MP TRANSDUCER 00884838034235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other