BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTI SPECT 2 [510(K) K913630]

    MDR report key: 326734 · Received April 13, 2001

    Report

    Report Number
    1423253-2001-00002
    Event Type
    Other
    Date Received
    April 13, 2001
    Date of Event
    November 15, 1999
    Report Date
    January 26, 2001
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    IYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN JANUARY 2001, SIEMENS MEDICAL SYSTEMS WAS INFORMED OF A PT INJURY THAT OCCURRED IN NOV. 1999. THERE WAS NO COMPLAINT OR MEDICAL REPORT FILED WITH THE MFR BY THE DEVICE USER. AFTER INVESTIGATION IT WAS DETERMINED THAT THE PT ROLLED OFF THE PT HANDLING SYSTEM ONTO THE FLOOR. THE MFR HAS DETERMINED THAT THERE WAS NO MALFUNCTION OF THE DEVICE TO CAUSE THE FALL. AT THE TIME OF NOTIFICATION, DETAILS WERE NOT AVAILABLE TO ALLOW A DECISION ON REPORTABLE NATURE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17143 MULTI SPECT 2 [510(K) K913630] GAMMA CAMERA IYX SIEMENS MEDICAL SYSTEMS K913630 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other