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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fracture, Arm (2351)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

Carestream health will investigate this incident and provide a follow up report when information is available.

Event Description

Customer alleges that due to contact with the carestream drx revolution mobile x-ray system, the user sustained a fractured arm.

Manufacturer Narrative

The incident was not reported to carestream health at the time of the event and because of that, valuable information that could have been collected about the circumstances of the incident was lost.Carestream health was only made aware of the incident 20 days later but the logs from the day of the event were no longer available on the unit.Our field engineer did not find a mechanical failure that could have caused erratic driving.In addition, this system was still being used after the incident, which shows there was not a mechanical failure of the system.The initial interview with the site indicated that the person injured was using the system in a non-standard way but we have not been able to confirm this due to the absence of logs.Therefore the root cause could not be established.No further updates will be sent, we will continue to monitor as part of our post-market surveillance process.

Event Description

Customer alleges that due to contact with the carestream drx revolution mobile x-ray system, the user sustained a fractured arm.

• Brand Name: CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM
• Type of Device: DRX REVO
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona st; rochester 14608
• Manufacturer (Section G): CARESTREAM HEALTH; 1049 ridge rd; rochester 14515
• Manufacturer Contact: michael callery ; 150 verona st; rochester 14608 ; 5856278230
• MDR Report Key: 6429873
• MDR Text Key: 70734799
• Report Number: 1317307-2017-00002
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other