BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNOVA 2121-IQ

    MDR report key: 3338323 · Received August 29, 2013

    Report

    Report Number
    9611343-2013-00024
    Event Type
    Other
    Date Received
    August 29, 2013
    Date of Event
    July 30, 2013
    Report Date
    July 31, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K060259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATION IS COMPLETED, THE HOSPITAL CONFIRMED THAT THE PATIENT EXPERIENCED LEFT SHOULDER PAIN WITHOUT FRACTURES OR DISLOCATION. THIS WAS CONFIRMED THROUGH X-RAY OF LEFT SHOULDER AND CT SCAN OF SPINE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STAYED 2 DAYS MORE FOR THE PLANNED DIAGNOSTIC EXAM (OUTPATIENT IS THE CURRENT STANDARD OF CARE) DUE TO OBSERVATION AND HAD X-RAY/CT SCAN, MEDICAL MANAGEMENT OF PAIN AND DELAYED CARDIAC CATHETERIZATION. INVESTIGATION OF THE FAILURE WAS PERFORMED AND IT WAS CONCLUDED THAT THE TABLETOP BREAKAGE WAS DUE TO A REVERSE LOADING THAT WAS EXERCISED ON THIS TABLETOP (FROM DOWNWARDS TO UPWARDS DIRECTION), WHICH WAS PROBABLY PERFORMED BY LOWERING THE TABLE WHILE HAVING AN EXTERNAL OBSTACLE UNDER THE TABLE (LIKE STRETCHER OR CART) AND COLLIDED WITH IT. THE REVERSE LOADING EXERCISED CREATED SOME INTERNAL CRACKS AND PRE-EXISTING TABLE DAMAGE. THE BREAKAGE OF THE TABLE TOP IS NOT DUE TO THE PATIENT WEIGHT BUT TO A STRESS RELATED TO A TABLETOP UPWARD BENDING. THIS IS A CASE OF MISUSE OF THE SYSTEM BY THE USER. INSTRUCTIONS ARE PROVIDED IN THE OPERATOR MANUAL TO THE USER TO CLEARLY WARN IT WHEN MOVING PARTS OF THE SYSTEM TO AVOID ANY COLLISION. GE HEALTHCARE DOES NOT EXPECT TO HAVE A SERIOUS INJURY FOR THIS FAILURE MODE BECAUSE UNDER THE GIVEN CONDITION, A SNAPPING OR BREAKING TABLE WILL CAUSE A PATIENT TO SLIDE OVER THE TABLE REMNANTS TO THE GROUND. THE DYNAMIC OF THE SLIDE AND THE SUBSEQUENT IMPACT ON THE PATIENT IS DEPENDING ON THE MECHANISM BY WHICH THE TABLE BREAKS. IN MANY CASES, THE BREAKING TABLE MIGHT STILL PROVIDE PARTIAL TEMPORARY SUPPORT, ALBEIT IN AN UNSTABLE MANNER, WHICH MAKES THE DOWN SLIDE OF THE PATIENT DIFFERENT FROM A FREE FALL FROM A GIVEN HEIGHT. THEREFORE, THE LIKELIHOOD OF HARM TO THE PATIENT, GIVEN THAT THE HAZARD HAS OCCURRED (THE TABLE SNAPPED OR BROKE), IS UNLIKELY. THE TABLE TOP HAS BEEN REPLACED BY A GE HEALTHCARE FIELD SERVICE ENGINEER ON (B)(4) 2013. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE TOP OF AN INNOVA 2121-IQ BROKE. THE PATIENT WAS POSITIONED ONTO THE VASCULAR TABLE TOP AND BEFORE THE START OF PROCEDURE, THE TABLE TOP BROKE. THE PATIENT SUSTAINED SHOULDER AND RIBS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428189 INNOVA 2121-IQ INTERVENTIONAL FLOUROSCOPIC X-RAY SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization