MAUDE Adverse Event Report: CARESTREAM HEALTH DRX REVOLUTION SYSTEM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

The investigation found that there was no device malfunction.The user accidentally drove the revolution over the individual's foot resulting in the broken bone.Therefore, since this was caused by the user's actions, there is no further action required by carestream health.The site did not report this incident to carestream health at the time it occurred.The site informed carestream health on november 14th, 2017 and stated that it happened sometime in (b)(6) 2017.

Event Description

The site reported that there was an incident in at the hospital in which a user drove over the foot of an individual, resulting in a broken bone in the individual's foot.

Manufacturer Narrative

The investigation found that there was no device malfunction.The user accidentally drove the revolution over the individual's foot resulting in the broken bone.Therefore, since this was caused by the user's actions, there is no further action required by carestream health.The site did not report this incident to carestream health at the time it occurred.The site informed carestream health on november 14th, 2017 and stated that it happened sometime in (b)(6) 2017.On 11 dec 2017 - the initial report submitted on nov 28 2017 listed the incorrect country where event occurred.The correct country is belgium.Follow up 1 contains this correction only.

Event Description

The site reported that there was an incident in at the hospital in which a user drove over the foot of an individual, resulting in a broken bone in the individual's foot.

• Brand Name: DRX REVOLUTION SYSTEM
• Type of Device: DRX REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH; 1049 ridge rd; rochester NY 14615
• Manufacturer Contact: mike callery ; 150 verona st; rochester, NY 14608 ; 5856278230
• MDR Report Key: 7062850
• MDR Text Key: 93047207
• Report Number: 1317307-2017-00017
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 12/11/2017

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other