BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA INTEVO 2

    MDR report key: 19627539 · Received June 27, 2024

    Report

    Report Number
    1423253-2024-00007
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    May 24, 2024
    Report Date
    August 7, 2024
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    UDI-DI
    04056869001227
    PMA / PMN Number
    K200474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON MAY 28, 2024, OF A SIEMENS CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2024. ALLEGEDLY, THE ENGINEER SUSTAINED A FINGER INJURY THAT REQUIRED SURGICAL INTERVENTION WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. THE SERVICE ENGINEER WAS TROUBLESHOOTING THE SYSTEM TRYING TO ISOLATE A NOISE RELATED TO THE PULLEY BELT. THE SERVICE ENGINEER PLACED THEIR FINGER TOO CLOSE TO THE BELT, WHICH ALLOWED CONTACT BETWEEN HIS FINGER AND THE MOVING BELT, AND CAUSING THE INJURY. NO LABELING OR PRODUCT DEFECTS WERE FOUND. THE DESCRIBED EVENT CANNOT CAUSE INJURY TO PATIENTS OR OPERATORS IN A CLINICAL SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827657 SYMBIA INTEVO 2 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 10764802 04056869001227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention