BEUDAMED
    FDA Adverse Event Death Summary report: N

    D-SPECT CARDIAC SYSTEM MODEL 003

    MDR report key: 11613013 · Received April 2, 2021

    Report

    Report Number
    MW5100530
    Event Type
    Death
    Date Received
    April 2, 2021
    Date of Event
    February 26, 2021
    Report Date
    March 31, 2021
    Manufacturer
    SPECTRUM DYNAMICS MEDICAL INC.
    Product Code
    KPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FELL FROM A NUCLEAR CAMERA WHICH RESULTED IN THE PATIENT BREAKING THEIR HIP. THE PATIENT EXPIRED AFTER THE HIP SURGERY WAS PERFORMED. IT IS BELIEVED THAT THE ROOT CAUSE OF THE FALL WAS A FAILURE OF THE ARM REST ON THE D-SPECT NUCLEAR CAMERA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508977 D-SPECT CARDIAC SYSTEM MODEL 003 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS SPECTRUM DYNAMICS MEDICAL INC. D-SPECT CARDIAC SYSTEM MODEL 003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death