BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMBIA S

    MDR report key: 3834418 · Received May 20, 2014

    Report

    Report Number
    1423253-2014-00003
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
    Product Code
    IYX
    PMA / PMN Number
    K131634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENT PROVIDES THE "DATE RECEIVED BY MANUFACTURER" INFORMATION.

    Description of Event or Problem · 1

    A PATIENT WAS PRESENTED FOR A NUCLEAR MEDICINE STUDY. THE PATIENT WAS POSITIONED ON THE PATIENT HANDLING SYSTEM (THE PATIENT BED ASSOCIATED WITH THE SYSTEM). THE PATIENT WAS LEFT UNATTENDED AND FELL OFF THE PATIENT HANDLING SYSTEM AND REPORTEDLY SUSTAINED AN INJURY TO THE HEAD. DURING SIEMENS' FOLLOW-UP WITH THE SITE FOR ADDITIONAL INFORMATION ON (B)(6) 2014, IT WAS REPORTED THAT THE PATIENT WAS REMOVED FROM LIFE SUPPORT AND HAD EXPIRED. SIEMENS WAS NOT ABLE TO OBTAIN INFORMATION REGARDING THE REASON THE PATIENT WAS REMOVED FROM LIFE SUPPORT OR ANY POTENTIAL RELATIONSHIP TO THE FALL FROM THE PATIENT HANDLING SYSTEM OR THE PATIENT'S PREEXISTING CONDITION; CANCER. LOCAL SERVICE ENGINEER INVESTIGATED THE SYSTEM ASSOCIATED WITH THE INCIDENT AND CONFIRMED THE PATIENT HANDLING SYSTEM WAS FUNCTIONING PROPERLY AND NO DEVICE DEFECTS OR MALFUNCTIONS WERE FOUND. THE SYSTEM WAS NOT IN MOTION AT THE TIME OF THE INCIDENT. A REVIEW OF THE PRODUCT USER MANUAL INDICATED THAT THE PRODUCT LABELING ADEQUATELY INSTRUCTS USERS TO MONITOR THE PATIENTS AT ALL TIMES WHILE ON THE SYSTEM AND THAT IT IS THE USER'S RESPONSIBILITY TO MONITOR THE SYSTEM TO AVOID ANY RISK OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298521 SYMBIA S GAMMA CAMERA IYX SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP 8717741

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R