BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 19434614 · Received May 31, 2024

    Report

    Report Number
    9610816-2024-00296
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    April 24, 2024
    Report Date
    September 17, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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. (B)(6) .

    Additional Manufacturer Narrative · 0

    (B)(4) IS NOW CONSIDERED A DUPLICATE OF (B)(4). PLEASE REFERENCE MFR REPORT NUMBER 9610816-2024-00297.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT SYSTEM IS CONTINUES TO DISPLAY VALUES THAT ARE TOO HIGH WITH THE FETAL HEART FREQUENCY 180BPM. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453755 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH M2736A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown