BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT VYNTUS ONE

    MDR report key: 22094210 · Received May 28, 2025

    Report

    Report Number
    9615102-2025-00172
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    March 21, 2025
    Report Date
    May 28, 2025
    Manufacturer
    JAEGER MEDICAL GMBH
    Product Code
    BZC
    UDI-DI
    04250892904696
    PMA / PMN Number
    K181524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS SUBMITTED LATER THAN REQUIRED BECAUSE THE INCIDENT, INITIALLY REPORTED BY THE CUSTOMER TO A JAEGER EMPLOYEE ON 21-MAR-2025, WAS NOT ESCALATED TO THE APPROPRIATE DEPARTMENT UNTIL 16-MAY-2025. THE DEVICE WAS NOT RETURNED FOR AN INVESTIGATION. A PRIOR CAPA INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THIS TYPE OF EVENT AS IMPROPER HANDLING OF THE ULTRASONIC SENSOR (USS). SPECIFICALLY, THE USS WAS USED AS A HANDLE TO REPOSITION THE SUPPORT ARM, RATHER THAN USING THE DESIGNATED HANDLE. THIS MISUSE CAN LOOSEN THE MECHANICAL CONNECTION BETWEEN THE USS AND THE FPV, COMPROMISING THE SENSOR¿S ABILITY TO REMAIN IN PLACE. AS A CORRECTIVE ACTION, THE INSTRUCTIONS FOR USE (IFU) WERE UPDATED TO EMPHASIZE PROPER HANDLING PROCEDURES. THE CUSTOMER WAS INFORMED REGARDING THE PROPER HANDLING OF THE DEVICE IN ACCORDANCE WITH THE IFU. THE RISK EVALUATION RESULTS AN ACCEPTABLE HEALTH RISK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PATIENT WAS SEATED FOR A LUNG FUNCTION TEST, THE CLINICIAN LOWERED THE ARM HOLDING THE ULTRASONIC FLOW SENSOR INTO POSITION. DURING THIS PROCESS, THE SENSOR HEAD BECAME DISLODGED FROM THE ARM AND STRUCK THE PATIENT ON THE FOREHEAD. THE PATIENT WAS PLACED UNDER OBSERVATION FOR 24 HOURS AND, ASIDE FROM EXPERIENCING MILD DERMATOLOGIC IRRITATION AND A TRANSIENT HEADACHE THE FOLLOWING DAY, SUSTAINED NO HARM. THERE WERE NO BRUISING OR CUTS OBSERVED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328440 PRODUCT VYNTUS ONE CALCULATOR, PULMONARY FUNCTION DATA BZC JAEGER MEDICAL GMBH PRODUCT VYNTUS ONE 04250892904696

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female