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

Model Number DRXR-1

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/05/2014

Event Type  Injury  

Event Description

Technologist (tech) #1 was attempting to pick up the revolution's power cord that fell into the column opening and at the same time another tech (tech #2) turned the column.As a result, tech #1 was injured (fractured the tip of a finger and tore part of her finger nail).

Manufacturer Narrative

The root cause of the incident is user error.While tech 1 was retrieving the plug end, tech 2 turned the column and tech 1's finger was injured.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYS
• Type of Device: DRX REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; rochester NY
• Manufacturer Contact: michael callery, reg affairs mgr ; 150 verona st.; rochester, NY 14608 ; 5856278230
• MDR Report Key: 3929305
• MDR Text Key: 4598575
• Report Number: 1317307-2014-00006
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2014

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: DRXR-1
• Device Catalogue Number: 1019397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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): Other