BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.CAM

    MDR report key: 3597182 · Received January 7, 2014

    Report

    Report Number
    1423253-2014-00001
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    November 27, 2013
    Report Date
    December 13, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
    Product Code
    KPS
    PMA / PMN Number
    K992731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SYSTEMS WHERE A SIMILAR EVENT MAY OCCUR (BUT HAVE NOT BEEN REPORTED): AFFECTED MODEL NUMBERS: 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823946, 07823953, 07823979, 10151531, 10151532, 10275879, 10413009, 10520745. THERE ARE THREE (3) APPLICABLE 510(K): E.CAM: K992731, SYMBIA E SINGLE/DUAL: K072567, K082506.

    Description of Event or Problem · 1

    WHILE TRANSFERRING THE SIEMENS ECAM SYSTEM HIGH ENERGY COLLIMATORS FROM THE CART, A RADIOGRAPHER HAD DIFFICULTIES WITH THE TRANSFER DUE TO THE COLLIMATOR STICKING HALF-WAY. IT WAS CONFIRMED BY A SIEMENS ENGINEER AND A CLINICAL SPECIALIST ON-SITE, THAT WHILE THIS OPERATION WAS HARDER THAN USUAL, IT WAS POSSIBLE TO PERFORM. THE LABELING WAS REVIEWED AND IS ADEQUATE: NOTE: WHEN INSTALLING/REMOVING HIGH-ENERGY COLLIMATORS, USE THE LUBRICANT PROVIDED TO LESSEN THE FRICTION BETWEEN THE COLLIMATOR AND THE COLLIMATOR SERVER. ON (B)(4) 2013 SIEMENS BECAME AWARE THAT THE RADIOGRAPHER INVOLVED HAD BEEN OFF WORK ON MEDICAL LEAVE OF ABSCENCE DUE TO BACK INJURY SUSTAINED WHILE MOVING THE COLLIMATORS. THIS EVENT TOOK PLACE IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11524 E.CAM GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP 5991109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention