BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM

    MDR report key: 10433549 · Received August 20, 2020

    Report

    Report Number
    3010151377-2020-00001
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 28, 2020
    Report Date
    September 14, 2020
    Manufacturer
    MOBIUS IMAGING, LLC
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE TECHNICIAN VISITED THE CUSTOMER SITE AND OBSERVED THAT THE UPPER RAIL BELT WAS COMPLETELY DAMAGED AND THE LOWER BELT WAS PARTIALLY DAMAGED. THE FIELD SERVICE TECHNICIAN REPLACED BOTH BELTS AND WAS ABLE TO SUCCESSFULLY COMPLETE ALL REQUIRED SCANS. THE AIRO WAS CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO STRYKER THAT DURING A HELICAL PATIENT SCAN PROCEDURE THE UPPER Z-BELT ON THE BASE OF THE AIRO SYSTEM WAS DAMAGED PREVENTING MOVEMENT OF THE AIRO GANTRY. THE CUSTOMER REPORTS THAT THE SURGERY DRAPES WAS OBSERVED TO BE STUCK BETWEEN THE Z-BELT AND MOTOR CAUSING THE REPORTED DAMAGE. THE CUSTOMER ATTEMPTED TO MANUALLY MOVE THE GANTRY WITHOUT SUCCESS. THE PATIENT'S TREATMENT WAS NOT COMPLETED AND WAS RESCHEDULED FOR THE FOLLOWING DAY. FOLLOW UP WITH THE FIELD SERVICE REPRESENTATIVE CONFIRMED THAT THERE WAS NO NEGATIVE PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO STRYKER THAT DURING A HELICAL PATIENT SCAN PROCEDURE THE UPPER Z-BELT ON THE BASE OF THE AIRO SYSTEM WAS DAMAGED PREVENTING MOVEMENT OF THE AIRO GANTRY. THE CUSTOMER REPORTS THAT THE SURGERY DRAPES WAS OBSERVED TO BE STUCK BETWEEN THE Z-BELT AND MOTOR CAUSING THE REPORTED DAMAGE. THE CUSTOMER ATTEMPTED TO MANUALLY MOVE THE GANTRY WITHOUT SUCCESS. THE PATIENT'S TREATMENT WAS NOT COMPLETED AND WAS RESCHEDULED FOR THE FOLLOWING DAY. FOLLOW UP WITH THE FIELD SERVICE REPRESENTATIVE CONFIRMED THAT THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896712 AIRO COMPUTED TOMOGRAPHY (CT) X-RAY SYSTEM AIRO MOBILE CT SYSTEM JAK MOBIUS IMAGING, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention