BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE E.CAM DUAL CAMERA

    MDR report key: 8750177 · Received July 1, 2019

    Report

    Report Number
    1423253-2019-00005
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 19, 2019
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K142006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED OF A SERVICE ENGINEER INJURY ON (B)(6) 2019. A SERVICE ENGINEER NEGLECTED TO FOLLOW PROCEDURE (B)(4) WHEN DE-INSTALLING (REMOVING) AN E.CAM GAMMA CAMERA FROM A CUSTOMER SITE. AS A RESULT, THE ENGINEER RECEIVED CONCUSSION AND LACERATION INJURIES TO HIS HEAD WHEN STRUCK BY A SYSTEM COMPONENT. THE ENGINEER WAS HOSPITALIZED AS A RESULT OF THE INJURIES. THERE ARE NO PRODUCT OR LABELING DEFICIENCIES OR MALFUNCTION. THERE WAS NO OTHER INJURY TO ANY OTHER PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541661 SIGNATURE E.CAM DUAL CAMERA GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 5989079

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R