BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19533377 · Received June 13, 2024

    Report

    Report Number
    9610816-2024-00336
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 8, 2024
    Report Date
    June 13, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    UDI-DI
    00884838002722
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICE IN QUESTION. FUNCTIONAL TESTING WAS PERFORMED AND RESULTS SHOWED THAT AFTER THE PROBE WAS TURNED ON, THERE IS NO REACTION. THE APPEARANCE OF THE PROBE WAS AGED AND DAMAGED. THE DEVICE SCREEN REPORTS AN ERROR: THE PROBE WAS DETERMINED TO BE FAULTY. BASED ON THE INFORMATION PROVIDED IN THE CASE AND BY THE FSE, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE THE WORN OUT PROBE. THE PROBE WAS REPLACED AND SCRAPPED DUE TO ITS AGE. AFTER THE PROBE REPLACEMENT, THE UNIT RETURNED TO SPECIFICATION. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. REPORTING INSTITUTION PHONE E1; (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE FETAL HEART WAVEFORM WAS ABNORMAL. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955597 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M2736A 00884838002722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown