BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSTAR PLUS

    MDR report key: 2966512 · Received February 18, 2013

    Report

    Report Number
    2240869-2013-11770
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 21, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    IZI
    PMA / PMN Number
    K884912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RELEVANT ROOT CAUSE COULD BE IDENTIFIED. EXPERTS STATED THAT EVEN IF A LOW BATTERY LEVEL IN PC BOARDS (ANG/D10 OR PUN/D10) MAY HAVE CAUSED THIS EVENT, AFTER A NUMBER OF REBOOTS THE SYSTEM WAS FUNCTIONING PROPERLY. INVESTIGATION DETAILS: EVALUATED SYSTEM LOG FILES WITH FOLLOWING RESULT: COLLIMATOR REPORTS CU-PRE-FILTER ERRORS; THE ANGIOMATIC REPORTS LOSS OF SOME CONFIGURATION DATA DUE TO LOW BACKUP BATTERY LEVEL, VARIOUS COMPONENTS REPORT PROBLEMS WITH X-RAY-RELEASE IN AN INVALID STATE, (POSSIBLE STICKY FOOTSWITCH). ALL OF THESE PROBLEMS WERE ALREADY REPORTED OVER SOME DAYS/WEEKS AND ALSO AT THE COMMUNICATED DATE/TIME OF THE EVENT. THE MOST LIKELY ROOT CAUSE FOR THE EVENT IS A LOW BATTERY LEVEL IN PC BOARDS ANG/D10 OR PUN/D10. THERE WERE NO OTHER HINTS FOR A POSSIBLE DIFFERENT ROOT CAUSE. PROTOCOLS SHOW THAT THE ANG-BATTERY HAS BEEN REPLACED IN ACCORDANCE WITH THE MAINTENANCE SCHEDULE. ACCORDING TO THE SERVICE ORGANIZATION, THE SYSTEM WAS REBOOTED SEVERAL TIMES AFTER THE EVENT WITHOUT ANY PROBLEMS VISIBLE. (B)(6)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PEDIATRIC NEEDLE BIOPSY OF THE LIVER, THE SYSTEM WOULD NOT MAKE X-RAY WHICH CAUSED A DELAY IN THE PROCEDURE. THE EXAM WAS ABORTED AND THE PATIENT WAS MOVED TO ANOTHER ROOM TO DO THE EXAM. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70111 ANGIOSTAR PLUS SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS AG 6379718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other