BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM D630

    MDR report key: 3529999 · Received December 4, 2013

    Report

    Report Number
    9613299-2013-00083
    Event Type
    Other
    Date Received
    December 4, 2013
    Date of Event
    August 12, 2013
    Report Date
    August 12, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K111445
    Removal / Correction Number
    9613299-06/20-2013-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS IDENTIFIED AS PRESENTING A DIFFERENT FAILURE MODE THAN THE ONE IDENTIFIED IN MDR# 9613299-2013-00001. THE SYSTEM IN MATTER IS A GE FACILITY SYSTEM IN THE EDUCATION CENTER. THIS SYSTEM IS UNDER DIRECT CONTROL OF GE. IT IS NOT USED FOR ANY CLINICAL PROCEDURES OF PATIENTS OR SCANNING OF ANY OTHER PERSON. AS SUCH, IT IS NOT LIKELY THAT SUCH A FAILURE ON THIS SYSTEM WILL LEAD TO ANY ADVERSE EVENT. THE FAILURE IDENTIFIED ON THIS SYSTEM RESULTS FROM THE FACT THAT IT IS BEING DISASSEMBLED OFTEN AS IT IS USED FOR TRAINING AND TROUBLESHOOTING. THE CAUSE FOR THE INSPECTION FAULT IS NOT CONSIDERED A MALFUNCTION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SERVICE ACTIVITY RELATED TO A FIELD ACTION, A GE HEALTHCARE FIELD ENGINEER IDENTIFIED GAPS BETWEEN THE LATERAL BLADES AND RELATED BEARING. NO SCREWS WERE LOOSE ON THE ASSOCIATED COMPONENTS. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629802 TANDEM D630 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1