BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EOS RADIOLUCENT CHAIR

    MDR report key: 6872886 · Received September 18, 2017

    Report

    Report Number
    3006165260-2017-00002
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    August 17, 2017
    Manufacturer
    EOS IMAGING
    Product Code
    INM
    UDI-DI
    03663999000061
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, (B)(4), EOS IMAGING REGIONAL APPLICATION SPECIALIST, RECEIVED A CALL FROM (B)(6), DIRECTOR OF RADIOLOGY AT (B)(6). IT WAS INITIALLY REPORTED THAT WHILE MOVING A PATIENT SEATED IN AN EOS RADIOLUCENT CHAIR INTO THE EOS SYSTEM GANTRY THE CHAIR FLIPPED OVER BACKWARDS. FORTUNATELY, THEY HAD 2 STAFF MEMBERS IN THE ROOM AND THE PATIENT WAS NOT INJURED. ADDITIONAL INFORMATION WAS REQUESTED BY (B)(4) AND RECEIVED THE SAME DAY FROM (B)(6), IT WAS REPORTED THE FOLLOWING: THE PATIENT WAS STRAPPED INTO THE CHAIR WHEN THIS HAPPENED. THEY WERE ATTEMPTING TO PUSH THE PATIENT UP THE RAMP AND INTO THE GANTRY. THE REAR WHEELS GOT CAUGHT ON THE ENTRY RAMP WHICH CAUSED THE CHAIR TO TIP OVER. PATIENT'S FAMILY WAS IN THE EOS ROOM AT THE TIME. THE ONSITE PHYSICIAN AND NURSES EXAMINED THE PATIENT AND NO PHYSICAL INJURIES WERE NOTICED. THERE WERE 3 TECHNOLOGISTS ATTEMPTING TO MOVE THE PATIENT INTO THE GANTRY WITH ONE AT EITHER SIDE AND THE OTHER AT THE FRONT OF THE CHAIR. THE CHAIR FELL COMPLETELY OVER AND INTO THE GANTRY. THEY MANAGED TO GET THE CHAIR UPRIGHT AND THE PATIENT WAS REMOVED FROM THE ROOM. PATIENT DETAILS ARE AS FOLLOWS: AGE-(B)(6). GENDER- MALE. WEIGHT- (B)(6). HEIGHT-154.9 CM. PATIENT IS ALSO WHEELCHAIR BOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652272 EOS RADIOLUCENT CHAIR RADIOLUCENT CHAIR INM EOS IMAGING EOS RADIOLUCENT CHAIR 03663999000061

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other