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

Model Number GMR40

Device Problem Structural Problem (2506)

Patient Problems Abrasion (1689); Bruise/Contusion (1754)

Event Date 09/21/2017

Event Type  Injury  

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 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
• Type of Device: DIGITAL RADIOGRAPHY GMR40
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics ave; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics ave; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923 ; 9785648500
• MDR Report Key: 6926628
• MDR Text Key: 88913647
• Report Number: 3004938766-2017-00010
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 10815411020298
• UDI-Public: 10815411020298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Radiologic Technologist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: GMR40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Date Manufacturer Received: 09/21/2017
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other