MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. CARESTREAM DRX-REVOLUTION MOBILE X-RAY SYSTEM

Model Number 5240-9357

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

Patient Problem Bone Fracture(s) (1870)

Event Date 10/01/2013

Event Type  Injury  

Event Description

A carestream fe reported that he thought that he had heard of a specific site where a tech had run the equipment over their toe which resulted in a fracture.The customer did not call carestream to report this issue.It was also related that this incident had occurred approximately 1-2 months ago, however, the actual date is unk.

Manufacturer Narrative

The customer did not report this issue to carestream.As stated on the first page of this report the fe had thought that they had heard of this issue at this site.The site has 4 drx-revolution mobile x-ray systems and the exact system where this issue occurred is unk.Each of the 4 systems have undergone the regularly scheduled preventive maintenance visits and there has not been any report of any system issues that would have caused or contributed to this incident.It is believed that this issue was a user accident.

• Brand Name: CARESTREAM DRX-REVOLUTION MOBILE X-RAY SYSTEM
• Type of Device: DRX-REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; rochester NY 14608
• Manufacturer Contact: susan pate ; 150 vera st; rochester, NY 14608 ; 5586276557
• MDR Report Key: 3558827
• MDR Text Key: 4054003
• Report Number: 1317307-2013-00019
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/20/2013

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?: No
• Device Operator: Health Professional
• Device Model Number: 5240-9357
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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): Required Intervention