MAUDE Adverse Event Report: EOS IMAGING EOS RADIOLUCENT CHAIR

Model Number EOS RADIOLUCENT CHAIR

Device Problems Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)

Patient Problem Fall (1848)

Event Date 08/17/2017

Event Type  malfunction  

Event 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
• Type of Device: RADIOLUCENT CHAIR
• Manufacturer (Section D): EOS IMAGING; 10 rue mercoeur; paris, paris 75011 ; FR 75011
• Manufacturer (Section G): EOS IMAGING; 10 rue mercoeur; paris, paris 75011 ; FR 75011
• Manufacturer Contact: bernard ismael ; 10 rue mercoeur; paris, paris 75011 ; FR 75011
• MDR Report Key: 6872886
• MDR Text Key: 87602329
• Report Number: 3006165260-2017-00002
• Device Sequence Number: 1
• Product Code: INM
• UDI-Device Identifier: 03663999000061
• UDI-Public: (01)03663999000061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EOS RADIOLUCENT CHAIR
• Device Catalogue Number: 9000113040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 48