BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.CAM IMAGING

    MDR report key: 17088225 · Received June 8, 2023

    Report

    Report Number
    1423253-2023-00001
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    December 3, 2021
    Report Date
    June 8, 2023
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K031825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS MEDICAL SOLUTIONS USA INC., ON MAY 9, 2023, THAT DURING THE REST PORTION OF A CARDIAC SCAN PERFORMED ON (B)(6) 2021, A PATIENT NEGLECTED TO FOLLOW THE USER-PROVIDED SAFETY BRIEFING/INSTRUCTIONS AND MOVED THEIR LEG OUT OF THE SCANNING AREA. THE DEVICE PERFORMED AS EXPECTED AND STOPPED MOTION UPON CONTACT. THE TREADMILL EXERCISE AND STRESS PORTION OF THE SCAN WERE THEN COMPLETED. ON (B)(6) 2023, THIS PATIENT SUBSEQUENTLY REPORTED A SERIOUS INJURY TO THEIR KNEE. SIEMENS MEDICAL SOLUTIONS USA INC. IS UNABLE TO SUBSTANTIATE OR CONFIRM THE SEQUENCE OF EVENTS AS THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2021 AND WAS NOT REPORTED TO THE MANUFACTURER UNTIL 2023. BASED ON DEVICE DESIGN AND TECHNICAL DEVICE INFORMATION, THE DEVICE IS HIGHLY UNLIKELY TO HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. THE DESCRIBED SCAN, WORKFLOW, AND SEQUENCE OF EVENTS ALSO MAKE IT HIGHLY UNLIKELY THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY EVENT. A RADIOLOGICAL ASSESSMENT CANNOT BE CONDUCTED BY THE MANUFACTURER. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276519 C.CAM IMAGING GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 08419009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention