MAUDE Adverse Event Report: NEUROLOGICA CORPORATION GMR40 RETROFIT KIT; DIGITAL RADIOGRAPHY GMR40

Model Number	GMR40
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A design modification will be implemented to the detector bin.This system has been taken out of service until this modification is put in place.Additionally, the foot crush label will be added to all systems in the field and/or in inventory.The noted design modification, which will focus on raising the gap distance to a more acceptable level where this injury will not recur or other like solution.A customer service bulletin will be formalized to detail this situation and communicate it to all application and service staff.
Event or Problem Description
The x-ray technologist, while transporting portable machine with the retrofit equipment in a backwards motion caught her left foot from the underside of the detector bin of the retrofit unit where it sits close to the floor.This caused an injury to her foot (i.E.Bruising and induced pain).

• Brand Name: GMR40 RETROFIT KIT
• Common Device Name: DIGITAL RADIOGRAPHY GMR40
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics ave; danvers MA 01923
• MDR Report Key: 6926628
• Report Number: 3004938766-2017-00010
• Device Sequence Number: 11090821
• Product Code: KPR
• UDI-Device Identifier: 10815411020298
• UDI-Public: 10815411020298
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K171085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Radiologic Technologist
• Remedial Action: Notification,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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?: Yes
• Operator of Device: Radiologic Technologist
• Device Model Number: GMR40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/07/2017
• 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