BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOM SIRESKOP SD

    MDR report key: 1934188 · Received December 17, 2010

    Report

    Report Number
    2240869-2010-00025
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 14, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    MQB
    PMA / PMN Number
    K051602
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS CHECKED BY THE LOCAL SERVICE ENGINEER, (B)(6), AND THE SYSTEM IS FUNCTIONING ACCORDING TO THE SPECIFICATIONS. NO EVIDENCE OF SYSTEM MALFUNCTION WAS FOUND. THE PROCEDURE FOR ATTACHING THE FOOTBOARD TO THE SYSTEM IS DESCRIBED IN DETAIL IN THE USER MANUAL FOR SIRESKOP SD (POINT NO. AXDI-240.620.09.01.02, SECTION "ACCESSORIES AND AUXILIARY DEVICES", PAGE 13-14). IF THE CUSTOMER ENSURES PROPER SEATING (LATCHING) OF THE FOOTBOARD, A DEATH OR SERIOUS INJURY IS UNLIKELY.

    Description of Event or Problem · 1

    DURING AN EXAM, THE CUSTOMER PLACED A PT ON THE TABLE AND TILTED THE SYSTEM. WHEN THE TABLE WAS AT ABOUT 60 DEGREES, THE FOOTBOARD LET GO AND THE PT SLID OF THE TABLE TO THE FLOOR, SUSTAINING NO INJURY. THE FOOTBOARD IS RATED FOR 400 LBS. SIEMENS LOCAL ENGINEER, (B)(6), CHECKED THE FOOTBOARD AND FOUND NOTHING WRONG WITH IT. HE PERFORMED MULTIPLE TESTS ON THE FOOTBOARD BY PLACING 450 LBS OF SAND BAGS OF THE FOOTBOARD AND TILTING THE TABLE. NO ISSUES WERE IDENTIFIED DURING THE TESTS. THE ENGINEER CHANGED THE FOOTBOARD AND SENT THE PART TO THE FACTORY FOR FURTHER INVESTIGATION. CUSTOMER'S ADDRESS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM SIRESKOP SD IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY MQB SIEMENS MEDICAL SOLUTIONS USA, INC. 8890415

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other