BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIA 3/8 HAWKEYE

    MDR report key: 4867683 · Received June 23, 2015

    Report

    Report Number
    9613299-2015-00006
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL F.I.
    Product Code
    KPS
    PMA / PMN Number
    K022960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THE PRIMARY ROOT CAUSE IS USE ERROR, BY NOT FOLLOWING THE OPERATOR INSTRUCTIONS: THE OPERATOR SET THE SYSTEM TO HOME POSITION THAT INCLUDES SWITCHING DETECTOR MODES; THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS TO OBSERVE THE PATIENT WITHIN THE SYSTEM AREA AND TO MONITOR THE POSITION OF THE PATIENT AND EQUIPMENT DURING SCAN PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFO IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS INJURED DURING USER-COMMANDED POST-EXAM PT POSITIONING OF A NUCLEAR MEDICINE IMAGING DEVICE. THE PT SUSTAINED A FRACTURED CHEEK BONE AND CONTUSIONS. PRELIMINARY INVESTIGATION INDICATES THAT THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405382 INFINIA 3/8 HAWKEYE SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL F.I.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other