MAUDE Adverse Event Report: CARESTREAM HEALTH INC DRX EVOLUTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

Carestream health investigated the incident and found that there was no malfunction.The root cause was that the user did not properly lock the grid before turning it resulting in it detaching from the device and striking the patient on the foot.There is no further action required by carestream health.

Event Description

The site alleges that the technician was using the wall stand for a chest exam.When the grid was turned it fell out and struck the patient on the foot, resulting in a fractured bone.

• Brand Name: DRX EVOLUTION SYSTEM
• Type of Device: DRX EVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH; 1049 ridge rd west; rochester NY 14615
• Manufacturer Contact: michael callery ; 150 verona st; rochester, NY 14608 ; 5856278230
• MDR Report Key: 7062905
• MDR Text Key: 93053104
• Report Number: 1317307-2017-00016
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K141837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other