BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMA

    MDR report key: 14620180 · Received June 7, 2022

    Report

    Report Number
    9613445-2022-00003
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 8, 2022
    Report Date
    August 10, 2022
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K192686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI : (B)(4). GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A THERMAL EVENT OCCURRED ON THE TOP OF THE PATIENT TABLE WHEN NO PATIENT WAS PRESENT. A PORTION OF THE SHEET WAS BURNED AND EXTINGUISHED. THERE WAS NO INJURY. A NEW CAMERA WAS REINSTALLED ACCORDING TO EXISTING INSTRUCTION TO REPAIR THE SYSTEM. THE INVESTIGATION DETERMINED THAT A RAT SHORT CIRCUITED THE HOSPITALS TRANSFORMER RESULTING IN A HIGH CURRENT CONDITION. BECAUSE THE AI CAMERA WAS IMPROPERLY INSTALLED, THE HIGH CURRENT CAUSED THE MOUNT BURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THERMAL EVENT OCCURRED ON THE TOP OF THE PATIENT TABLE WHEN NO PATIENT WAS PRESENT. A PORTION OF THE SHEET WAS BURNED AND EXTINGUISHED. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577710 MAXIMA COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE HANGWEI MEDICAL SYSTEMS CO., LTD. CSPL63

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other