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

Device Problem Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

The investigation found that per the customer report, the drx revolution did not malfunction and the site continued to use it after the incident occurred.The tech was holding the door open with one hand while reversing the drx revolution through the doorway, while trying to get out of the room the device ran over her foot.Per the customer description of the event and the information obtained by carestream customer care, this incident was caused by the user not following the instructions for use (ifu).The ifu's state (by diagram) that the user should operate the device with both hands on the drive handle while positioned directly behind the device.In this case the user was standing on the side of the unit and operating it with one hand.

Event Description

Technologist was driving in reverse mode and the drx revolution ran over her toe resulting in a fracture.

• Brand Name: DRX MOBILE REVOLUTION SYSTEM
• Type of Device: DRX REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC; 1049 ridge rd west; rochester NY 14615
• Manufacturer Contact: michael callery ; carestream health inc; 150 verona st; rochester, NY 14608 ; 5856278230
• MDR Report Key: 6585311
• MDR Text Key: 75771847
• Report Number: 1317307-2017-00011
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• 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
• Date Manufacturer Received: 05/08/2017
• 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