BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1840111 · Received September 15, 2010

    Report

    Report Number
    9617766-2010-00528
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    June 10, 2010
    Report Date
    September 15, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT DISCLOSED WHETHER OR NOT THE SYSTEM WAS REPAIRED BY A GE HEALTHCARE ENGINEER. NO CONCLUSION CAN BE DRAWN. HOWEVER, NO REPORT OF PT INJURIES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHEN THE SYSTEM HEATED UP THE IMAGES DISAPPEARED. ALSO, THE SYSTEM LOST PT DATA. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOPE FLUOROSCOPY XRAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1