BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA INTEVO BOLD

    MDR report key: 9854182 · Received March 19, 2020

    Report

    Report Number
    1423253-2020-00001
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    February 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K162483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE APPOINTMENT ON MARCH 09, 2020, SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED OF A PATIENT INJURY THAT OCCURRED ON (B)(6) 2020. A PATIENT WAS IMPROPERLY POSITIONED WITH A NON-SIEMENS ACCESSORY AND WAS UNATTENDED DURING THE AUTOMATED SYSTEM MOTIONS. DURING MOTION, THE DETECTOR CONTACTED THE PATIENT AND THE PATIENT RECEIVED A SKIN LACERATION THAT REQUIRED STITCHES. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. PRODUCT LABELING INCLUDES INSTRUCTIONS TO MONITOR PATIENTS AND TO USE ONLY SIEMENS ACCESSORIES. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315481 SYMBIA INTEVO BOLD GAMMA CAMERA, PRODUCT CODE KPS KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 11007962

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention