MAUDE Adverse Event Report: CARESTREAM HEALTH INC DRX MOBILE REVOLUTION SYSTEM; DRX REVO

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

Patient Problem Death (1802)

Event Date 08/30/2017

Event Type  Death  

Manufacturer Narrative

Carestream health is investigating this incident.The facts currently available indicate that the incorrect image being read was not due to a device malfunction of the system but, due to an error by the medical staff processing and reading the image.The patient has since expired and the hospital has not provided a cause of death.A follow up mdr will be submitted once more facts become available.

Event Description

A patient was imaged using the drx revolution.The radiologist read the resultant image as an antero-posterior exam, when it actually was a postero-anterior.As a result, a procedure that was supposed to be performed on one lung was performed on the other lung.The patient has expired and the date is unknown at this time.

Manufacturer Narrative

The customer alleged that the image was sent directly from the revolution to the customer pacs.If this were the case, this would mean that the revolution automatically sent the image in the incorrect orientation.The image that lead to the event was obtained from the customer's pacs and reviewed by carestream personnel.This review showed that the image was viewed and modified (left-marker & sticky note) prior to being sent to pacs.If the image was sent automatically to pacs after image capture, there would be no l-marker and no sticky note added.Based on this evidence, the customer allegation that the image at the time of the event went automatically to the pacs without qa approval is not possible.There was no device malfunction and there is no further action required by carestream.

Event Description

A patient was imaged using the drx revolution.The radiologist read the resultant image as an antero-posterior exam, when it actually was a postero-anterior.As a result, a procedure that was supposed to be performed on one lung was performed on the other lung.The patient has expired and the date is unknown at this time.

• Brand Name: DRX MOBILE REVOLUTION SYSTEM
• Type of Device: DRX REVO
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: michael callery ; 150 verona st; rochester, NY 14608
• MDR Report Key: 6861526
• MDR Text Key: 85944285
• Report Number: 1317307-2017-00015
• 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,user f
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death