MAUDE Adverse Event Report: EOS IMAGING EOS SYSTEM

Model Number EOS

Device Problems Failure To Adhere Or Bond (1031); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Arthralgia (2355)

Event Date 04/14/2017

Event Type  Injury  

Event Description

On (b)(4) 2017, the following event was reported to (b)(4) by (b)(6).(b)(6), manager of hospital equipment, sent an email to (b)(4), manager, informing him of the fall of a patient upon entrance in the eos system cabin that occurred the same day.According this preliminary information, the patient relied on two handles attached by suction cups on part of the entry; the left handle detached from its carrier, causing the patient to fall.In her message, (b)(6) joined the incident report which states the following: "· the patient, during his hospitalization, was supported as part of a full spine eos standing exam.The patient arrived on a chair but could hold the standing position.To settle in the cabin, the patient took support on the handles designed for this purpose (mobeli stabi vario reference 14002 96 s) produced by the roth company in order to go up on the machine stand.The left handle dropped suddenly during this action, causing the patient to fall.The patient fell from his height and complained of pain in his right shoulder after being helped up.The patient did not lose consciousness after falling.A radiologist has come to see the patient condition.The service in which the patient was hospitalized has been notified of the incident to observe a possible evolution of the patient's condition.The defective handle has been contained." a site visit was made on (b)(4) 2017 by((b)(4).To assess the state of the second handle that remained in place as well as the state of the surfaces on which were attached the suction cups, and to understand the process followed by the hospital to install these handles and monitor their outfit, and get back the two handles for investigation.

Manufacturer Narrative

This follow-up report is being submitted to reflect the device that was used (eos system) when the reported event occurred involving the roth mo beli stabi vario grab handle.The grab handle was supplied with the eos system which is manufactured by eos imaging and imported by (b)(4).The grab handle was supplied with the intention to be used with the eos system.(b)(4) has updated this report with the eos system manufacturer and importer information.The roth mobeli stabi vario grab handle is listed as a concomitant device.

Event Description

Refer to initial report.

Manufacturer Narrative

Conclusion of product analysis: the handles used by the site showed obvious signs of wear, no longer allowing safe use of these accessories on the eos system.Additionally, the handles were not used per labeled intended use (leaflet d14.595.12.06) stating: "only for stabilizing the hand or arm and for fixing the hand by pressing the stabilization grip on any smooth, gastight surface: such as wash-basin, on the table of the wheelchair, desks,.Attention: don't use the grip as an aid for standing up or as a holding grip!" labeled instructions are very clear on intended use and monitoring and maintenance measures to be taken such as the safety indicator.However these instructions were provided in english and german only to the french customer, which didn't probably allow him to fully understand the intended use of the handles, monitoring and maintenance measures.On june 1, 2017, eos imaging has initiated a medical device removal of the roth mobeli grab handles used with eos system: the stabi vario model involved in the incident but also the dual grip model (model # 14002 25 s) distributed by eos imaging and that uses the same operating principle as the stabi vario handle.This field safety corrective action bears internal reference (b)(4) and has been notified to fda on may 31, 2017 ((b)(4)).

Event Description

Refer to initial report.

• Brand Name: EOS SYSTEM
• Type of Device: EOS SYSTEM
• Manufacturer (Section D): EOS IMAGING; 10 rue mercoeur; paris, 75011 ; FR 75011
• MDR Report Key: 6563217
• MDR Text Key: 75033901
• Report Number: 3008632827-2017-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017,06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: EOS
• Device Catalogue Number: EOS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2017
• Distributor Facility Aware Date: 04/14/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR