BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECAM

    MDR report key: 485061 · Received September 26, 2003

    Report

    Report Number
    1423253-2003-00002
    Event Type
    Death
    Date Received
    September 26, 2003
    Date of Event
    September 18, 2003
    Report Date
    September 19, 2003
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., NM GROUP
    Product Code
    KPS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NUCLEAR MEDICINE TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THAT THE SYSTEM WAS IN USE ON A PT FOR A WHOLE BODY STUDY. A FOLEY CATHETER WAS IN PLACE IN THE PT. THE URINE BAG WAS PLACED ON THE FOOT END OF THE "PHS." THE BAG SLIPPED FROM THE END OF THE PALLET, THE PALLET TRAVELED NORMALLY AS TYPICAL FOR A WHOLE BODY STUDY AND EVENTUALLY THE CATHETER WAS PULLED FROM THE PT. THE PT WAS INJURED AND EXPIRED. THE CAUSE OF DEATH IS UNKNOWN TO SIEMENS. THE SERVICE ENGINEER VISITED THE SITE AND THERE WAS NO EQUIPMENT MALFUNCTION OR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECAM GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC., NM GROUP 7333250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death