BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS M2725A WIRELESS TOCO TRANSDUCER

    MDR report key: 8773874 · Received July 9, 2019

    Report

    Report Number
    3007409280-2019-00002
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    May 9, 2016
    Report Date
    May 9, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    HGM
    PMA / PMN Number
    K023931
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO AVANTE HEALTH SOLUTIONS (AHS) FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND DID NOT IDENTIFY ANY ISSUES. TESTING WAS PERFORMED BY KEEPING THE DEVICE PLUGGED IN OVER A TWO-DAY PERIOD WHICH DETERMINED THAT THERE WAS NO HEAT GENERATING FROM THE DEVICE. THERE WERE NO OTHER ISSUES IDENTIFIED. THE BATTERIES WERE EXCHANGED IN THE DEVICE FOR NEW ONES AND THERE WERE STILL NO ISSUES FOUND. A ROOT CAUSE FOR THE REPORTED PATIENT BURN AND BLISTER CANNOT BE DETERMINED. NO FURTHER ACTION IS REQUIRED. AVANTE HEALTH SOLUTIONS WILL CONTINUE TO MONITOR THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS BURNED DURING USE OF THE FETAL TRANSDUCER CREATING A BLISTER ON THE PATIENT'S STOMACH. THERE WAS NO REPORT OF INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567670 PHILIPS M2725A WIRELESS TOCO TRANSDUCER TOCOTRANSDUCER HGM PHILIPS MEDICAL SYSTEMS, INC. M2752-60001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other