BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM EMOTION 16 (2007)

    MDR report key: 8975837 · Received September 9, 2019

    Report

    Report Number
    3004977335-2019-95923
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 28, 2019
    Report Date
    August 28, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAK
    PMA / PMN Number
    K050297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SIEMEN'S INVESTIGATED THE REPORTED INCIDENT. THE ROOT CAUSES ARE IDENTIFIED AS FAILURE OF THE CUSTOMER TO REPAIR THE DAMAGED TABLE BEFORE USE DURING PATIENT TREATMENT AND NOT PROPERLY FIXATING THE PATIENT'S ARM DURING TREATMENT. THE REPORTED DEVICE DID NOT MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL REPORTABLE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT DURING USE OF THE SOMATOM EMOTION 16 (2007) A MODERATE PATIENT INJURY OCCURRED. THE PATIENT'S FINGER WAS CAUGHT BETWEEN THE SYSTEM TABLE AND GANTRY COVER AND THE PATIENT'S SKIN WAS LACERATED BY THE SHARP EDGES OF THE PREVIOUSLY DAMAGED TABLE COVER. THE WOUND WAS TREATED DURING A BRIEF MEDICAL INTERVENTION TO STOP THE BLEEDING. THERE IS NO PERMANENT INJURY EXPECTED DUE TO THE EVENT. THE TABLE COVER WAS REPORTEDLY DAMAGED BEFORE THE REPORTED EVENT. THE EVENT IS NOT ASSOCIATED WITH AN IDENTIFIED DEVICE MALFUNCTION. THE SOURCE OF THE TABLE DAMAGE WAS NOT REPORTED BY THE CUSTOMER, NOR WAS SIEMENS NOTIFIED TO REPAIR IT BEFORE THE PATIENT EVENT. THE STRAP USED TO FIXATE PATIENT'S ARMS BECAME LOOSE AND THE PATIENT'S ARM SLIPPED INTO THE GAP BETWEEN THE DAMAGED TABLE AND THE GANTRY WHILE THE TABLE WAS MOVED INTO THE GANTRY. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769177 SOMATOM EMOTION 16 (2007) SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHCARE GMBH 1025253055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention