BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON CABLELESS TOCO+ MP TRANSDUCER

    MDR report key: 23312353 · Received October 16, 2025

    Report

    Report Number
    9610816-2025-000959
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 27, 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
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE CONFIRMED THAT THE UNIT MANAGER DID NOT SEQUESTER DEVICES FOR EVALUATION. THE DEVICE WAS ADDED BACK TO THE DEVICE POOL. THE INVESTIGATION DID FIND THAT THE CUSTOMER IS USING UNAPPROVED DISINFECTANT WIPES. ADDITIONALLY, THE CUSTOMER IS NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH INSTRUCT THAT THE DEVICE BE WIPED OFF WITH A CLOTH DAMPENED WITH WATER, AFTER ALLOWING THE APPROPRIATE TIME FOR AGENT TO WORK. PER THE AVALON FETAL MONITOR FM20/30, FM40/50, AVALON CL, RELEASE L.3 WITH SOFTWARE REVISION L.3X.XX INSTRUCTIONS FOR USE, PART NUMBER 453564898421 P. 258 WARNING SKIN CONTACT: TO REDUCE THE RISK OF SKIN IRRITATIONS, DO NOT ALLOW A CLEANING OR DISINFECTING AGENT TO LEAVE RESIDUES ON ANY OF THE EQUIPMENT SURFACES - WIPE IT OFF WITH A CLOTH DAMPENED WITH WATER, AFTER ALLOWING THE APPROPRIATE TIME FOR THE AGENT TO WORK. . FOLLOW THE SAFETY INSTRUCTIONS OF THE USED CLEANING OR DISINFECTION AGENT, ESPECIALLY REGARDING SKIN CONTACT. A DEVICE MALFUNCTION WAS NOT CONFIRMED. THE CUSTOMER WAS ADVISED TO FOLLOW THE CLEANING PROTOCOL PROVIDED IN THE IFU. THE CUSTOMER HAS AGREED TO SEQUESTER ANY OTHER DEVICES EXHIBITING THE ISSUE IN THE FUTURE AND TO NOTIFY PHILIPS IMMEDIATELY. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THE PRELIMINARY INVESTIGATION INDICATES THAT THE CUSTOMER IS USING AN UNAPPROVED DISINFECTING AGENT WHEN CLEANING THE DEVICE. ADDITIONALLY, THE DEVICE IS NOT WIPED FOLLOWING THE CLEANING. THE PRODUCT INSTRUCTIONS FOR USE INDICATE THE FOLLOWING: WARNING SKIN CONTACT: TO REDUCE THE RISK OF SKIN IRRITATIONS, DO NOT ALLOW A CLEANING OR DISINFECTING AGENT TO LEAVE RESIDUES ON ANY OF THE EQUIPMENT SURFACES - WIPE IT OFF WITH A CLOTH DAMPENED WITH WATER, AFTER ALLOWING THE APPROPRIATE TIME FOR THE AGENT TO WORK. . FOLLOW THE SAFETY INSTRUCTIONS OF THE USED CLEANING OR DISINFECTION AGENT, ESPECIALLY REGARDING SKIN CONTACT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BLISTERS WERE PRESENT ON THE PATIENT UNDER THE ULTRASOUND TRANSDUCER DURING USE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098646 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 Female Other