BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 4100-IQ

    MDR report key: 4339849 · Received December 12, 2014

    Report

    Report Number
    9611343-2014-00077
    Event Type
    Injury
    Date Received
    December 12, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 14, 2014
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED. ON (B)(6) 2014, GE HEALTHCARE WAS INFORMED THAT DURING THE PREPARATION OF THE PROCEDURE, THE (B)(6) YEAR OLD, VERY ILL AND FRAGILE FEMALE INPATIENT PRESENTED FOR A MINOR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE PATIENT'S CONDITION WAS LETHARGIC AND IN SEVERE RESPIRATORY DISTRESS WITH A HISTORY OF RHEUMATOID ARTHRITIS AND COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE). PATIENT WAS SUPPORTED BY 3 TECHNICIANS DURING PATIENT TRANSFER. AFTER THE TRANSFER, 2 TECHNICIANS LEFT THE ROOM AND THE THIRD TECHNICAL WAS BUSY PUTTING LEAD ON AND SCRUBBING. THE PATIENT ON THE TABLE WAS UNATTENDED AND NO VELCRO STRAPS WERE UTILIZED TO IMMOBILIZE THE PATIENT. THE UNATTENDED PATIENT ROLLED OFF THE TABLE AND FELL TO THE FLOOR. AFTER THE FALL, THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT. A CT OF HEAD AND SPINE WERE NEGATIVE BUT FRACTURES WERE DIAGNOSED AFTER X-RAYS WERE TAKEN. PATIENT WAS NOT IN A LIFE THREATENING STATE AFTER THE FALL AND WAS NOT TREATED FOR THE FRACTURES. THE PATIENT WAS SAFELY TRANSPORTED (AS PER A PLAN PRIOR TO THE PATIENT'S FALL) TO ANOTHER FACILITY TO CONTINUE CARE FOR THE ORIGINAL UNDERLYING CO-MORBIDITIES. THE PATIENT DIED 10 DAYS LATER FROM UNKNOWN CAUSE. THE FACILITY STATED THAT THE SYSTEM DID NOT MALFUNCTION AND THEY DID NOT HAVE ANY PROBLEMS WITH THE SYSTEM. IT WAS CONFIRMED THAT THE GE HEALTHCARE SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. GE HEALTHCARE'S FIELD SERVICE ENGINEER CONFIRMED THAT VELCRO STRAPS AND THE HEAD HOLDER THAT ARE PART OF THE INTERVENTIONAL PRODUCT WERE SUPPLIED AND AVAILABLE ALONG WITH THE TABLE. CUSTOMER APPLICATION TRAINING WAS PERFORMED AFTER THE COMPLETION OF SYSTEM INSTALLATION TO COVER THE INFORMATION ABOUT THE USAGE OF VELCRO STRAPS TO SUPPORT THE PATIENT ON THE TABLE. TECHNICIANS ARE EXPERIENCED AND AWARE OF THE VELCRO STRAPS AND CONFIRMED TO GE HEALTHCARE THEY USE THE VELCRO STRAPS WHEN THEY FIND A PATIENT AGITATED. IN THIS CASE, THEY DID NOT FIND THE PATIENT TO BE RESTLESS. INSTRUCTIONS CONTAINED INTO THE OPERATOR MANUAL RECOMMEND THE USAGE OF VELCRO STRAPS AND CLEARLY WARNS NOT TO LEAVE THE PATIENT UNATTENDED/UNSUPERVISED ON THE TABLE. THE ROOT CAUSE IDENTIFIED FOR THIS ISSUE IS THAT USER LEFT THE PATIENT UNGUARDED AND UNSECURED WITHOUT VELCRO STRAPS AGAINST THE INSTRUCTIONS FOR USE AND IN-SERVICE TRAINING RECOMMENDATION. THERE WAS NO SYSTEM MALFUNCTION. THREE ATTEMPTS WERE MADE TO OBTAIN INFORMATION; HOWEVER ADDITIONAL PATIENT INFORMATION WAS NOT PROVIDED. ON (B)(6) 2015, GE HEALTHCARE'S FIELD SERVICE ENGINEER REMINDED THE HOSPITAL'S HEAD TECHNICIAN TO USE THE VELCRO STRAPS AND SECURE THE PATIENT PER RECOMMENDATIONS IN THE OPERATOR MANUAL. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS PATIENT DIED AT THE OTHER FACILITY 10 DAYS LATER. GE HEALTHCARE VASCULAR SYSTEM CONTRIBUTED TO THE PATIENT'S SERIOUS INJURY (THE FRACTURES THAT INCURRED AFTER THE PATIENT'S ROLLING OFF THE TABLE TO THE FLOOR) AS IT WAS IN USE AT THE TIME OF THE PATIENT FALL. HOWEVER, IT WS CONFIRMED THAT THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ROLLED OFF THE TABLE. NO SAFETY STRAPS WERE USED AND DURING UNSUPERVISED PERIOD THE PATIENT FELL OFF THE TABLE RESULTING IN A LEFT FEMORAL AND RIGHT HUMERAL FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808145 INNOVA 4100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other