BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIL VG HAWKEYE

    MDR report key: 5309555 · Received December 18, 2015

    Report

    Report Number
    9613299-2015-00013
    Event Type
    Death
    Date Received
    December 18, 2015
    Date of Event
    November 20, 2015
    Report Date
    March 15, 2016
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K953801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. DATE OF MANUFACTURE IS UNKNOWN. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A THIN, CONSCIOUS FEMALE WITH SEVERE LUNG DISEASE WAS PLACED, TOGETHER WITH THE STRETCHER MATTRESS, ONTO THE VG CRADLE MATTRESS AND LOOSELY STRAPPED. A STATIC PULMONARY FUNCTION EXAM WAS COMPLETED. DURING IMAGE REVIEW, THE PATIENT SLID OFF THE CRADLE AND WEDGED HER BODY BETWEEN THE CRADLE AND ADJACENT VG GANTRY. EMERGENCY STOP BUTTON WAS INITIATED 30 SECONDS AFTER THE CT PORTION OF THE SCAN WAS INITIATED. PATIENT WAS ENTRAPPED AND EXTRACTED BY STAFF. IT IS UNKNOWN WHAT (IF ANY) FORCES WERE EXERTED ON THE PATIENT AND IF ANY FIRST ORDER PHYSICAL INJURY OCCURRED FROM THE VG SYSTEM. THE PATIENT EXPIRED 3 HOURS LATER. AS THE CUSTOMER WAS NOT WILLING TO TAKE PART IN THE INVESTIGATION, IT WAS IMPOSSIBLE TO CONCLUDE THE EXACT SEQUENCE OF EVENTS THAT LED TO THE PATIENT FALLING INTO THE BORE. HOWEVER, BASED ON THE SEQUENCE OF EVENTS AND FACTS AS PROVIDED BY THE POLICE, IT WAS CONCLUDED THAT THE REPORTED INCIDENT OCCURRED AS A RESULT OF THE FOLLOWING USE ERRORS: THE OPERATOR DID NOT FOLLOW THE USER INSTRUCTIONS TO ENSURE PATIENT WAS PROPERLY SECURED BY USING MATTRESS ON MATTRESS AND BY NOT TIGHTENING THE MATTRESS STRAPS AROUND THE PATIENT. 2. THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS TO OBSERVE THE PATIENT WITHIN THE SYSTEM AREA AND TO MONITOR THE POSITION OF THE PATIENT DURING SCAN PROCEDURES. SW LOGS ANALYSIS INDICATES THAT NO SYSTEM MALFUNCTION IS IDENTIFIED AND THAT THE SYSTEM WAS CONTINUED TO BE USED FOR SCANS ON THE DAY OF THE EVENT AND THE FOLLOWING DAYS. WITH THE ABOVE INFORMATION, THE ROOT CAUSE FOR THE PATIENT INCIDENT HAS BEEN DETERMINED TO BE A USE ERROR BY THE TECHNICIAN WHO DID NOT FOLLOW THE OPERATING INSTRUCTIONS. A THIN, CONSCIOUS FEMALE WITH SEVERE LUNG DISEASE WAS PLACED, TOGETHER WITH THE STRETCHER MATTRESS, ONTO THE VG CRADLE MATTRESS AND LOOSELY STRAPPED. A STATIC PULMONARY FUNCTION EXAM WAS COMPLETED. DURING IMAGE REVIEW, THE PATIENT SLID OFF THE CRADLE AND WEDGED HER BODY BETWEEN THE CRADLE AND ADJACENT VG GANTRY. EMERGENCY STOP BUTTON WAS INITIATED 30 SECONDS AFTER THE CT PORTION OF THE SCAN WAS INITIATED. PATIENT WAS ENTRAPPED AND EXTRACTED BY STAFF. IT IS UNKNOWN WHAT (IF ANY) FORCES WERE EXERTED ON THE PATIENT AND IF ANY FIRST ORDER PHYSICAL INJURY OCCURRED FROM THE VG SYSTEM. THE PATIENT EXPIRED 3 HOURS LATER. AS THE CUSTOMER WAS NOT WILLING TO TAKE PART IN THE INVESTIGATION, IT WAS IMPOSSIBLE TO CONCLUDE THE EXACT SEQUENCE OF EVENTS THAT LED TO THE PATIENT FALLING INTO THE BORE. HOWEVER, BASED ON THE SEQUENCE OF EVENTS AND FACTS AS PROVIDED BY THE POLICE, IT WAS CONCLUDED THAT THE REPORTED INCIDENT OCCURRED AS A RESULT OF THE FOLLOWING USE ERRORS: THE OPERATOR DID NOT FOLLOW THE USER INSTRUCTIONS TO ENSURE PATIENT WAS PROPERLY SECURED BY USING MATTRESS ON MATTRESS AND BY NOT TIGHTENING THE MATTRESS STRAPS AROUND THE PATIENT. THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS TO OBSERVE THE PATIENT WITHIN THE SYSTEM AREA AND TO MONITOR THE POSITION OF THE PATIENT DURING SCAN PROCEDURES. SW LOGS ANALYSIS INDICATES THAT NO SYSTEM MALFUNCTION IS IDENTIFIED AND THAT THE SYSTEM WAS CONTINUED TO BE USED FOR SCANS ON THE DAY OF THE EVENT AND THE FOLLOWING DAYS. WITH THE ABOVE INFORMATION, THE ROOT CAUSE FOR THE PATIENT INCIDENT HAS BEEN DETERMINED TO BE A USE ERROR BY THE TECHNICIAN WHO DID NOT FOLLOW THE OPERATING INSTRUCTIONS

    Description of Event or Problem · 1

    GE HEALTHCARE BECAME AWARE OF A PATIENT'S DEATH, INVOLVING A (B)(6) FEMALE, THAT OCCURRED IN (B)(6) ON (B)(6). ACCORDING TO INFORMATION RECEIVED FROM THE HEALTH FACILITY, THE PATIENT FELL OFF THE CRADLE. THE MEDICAL PERSONNEL OF THE HOSPITAL INFORMED GEHC THAT THEY CANNOT DISCUSS FURTHER DETAILS ABOUT THE INCIDENT. CURRENTLY A FORMAL INVESTIGATION IS BEING DONE BY LOCAL AUTHORITIES. GEHC HAS NOT BEEN ALLOWED ONSITE TO INVESTIGATE THE DEVICE AT THIS TIME, BUT WILL CONTINUE TO WORK WITH THE FACILITY TO SUPPORT THEIR INVESTIGATION INTO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837102 MIL VG HAWKEYE SYSTEM, TOMOGRAPHY, COMPUTED, EMIS KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death