MAUDE Adverse Event Report: EOS IMAGING EOS RADIOLUCENT CHAIR

Model Number	EOS RADIOLUCENT CHAIR
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: EOS RADIOLUCENT CHAIR
• Common Device Name: RADIOLUCENT CHAIR
• Manufacturer (Section D): EOS IMAGING; 10 rue mercoeur; paris, paris 75011 ; FR 75011
• MDR Report Key: 6872886
• Report Number: 3006165260-2017-00002
• Device Sequence Number: 13612396
• Product Code: INM
• UDI-Device Identifier: 03663999000061
• UDI-Public: (01)03663999000061
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EOS RADIOLUCENT CHAIR
• Device Catalogue Number: 9000113040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Weight: 48