BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA T6

    MDR report key: 15414149 · Received September 13, 2022

    Report

    Report Number
    1423253-2022-00002
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 30, 2022
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K162337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON AUGUST 31, 2022, OF A PATIENT INJURY THAT OCCURRED ON (B)(6), 2022, AT THE END OF AN ACQUISITION. MOTION WAS INITIATED BY THE OPERATOR TO REMOVE THE PATIENT. THE OPERATOR FAILED TO FOLLOW THE INSTRUCTIONS TO KEEP BODY PARTS AWAY FROM THE CONTACT AND PINCH POINTS WITHIN THE PATIENT BED PALLET. AS A RESULT, THE PATIENT'S FINGERS WERE CAUGHT IN A PATIENT BED PALLET PINCH POINT. THE PATIENT SUSTAINED AN INJURY TO THE FOURTH AND FIFTH FINGERS OF THE LEFT HAND THAT REQUIRED SURGICAL INTERVENTION. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969898 SYMBIA T6 GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 10275009

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention