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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Laceration(s) (1946)

Event Date 06/17/2018

Event Type  Injury  

Manufacturer Narrative

Carestream is in the process of investigating this incident and will provide an update when additional facts become available.

Event Description

The customer site alleged that the rad tech backed over her foot when reversing the device out of an elevator.The tech required stitches on her nail bed and was out of work for one week.

Event Description

The customer site alleged that the rad tech backed over her foot when reversing the device out of an elevator.The tech required stitches on her nail bed and was out of work for one week.

Manufacturer Narrative

Carestream health has evaluated the device.The investigation found that there was no device malfunction and the incident was caused by the user not following the instructions for use (ifu).The user admitted that they did not use both hands to drive the drx mobile revolution system as specified in the ifu.There are no further actions to be taken by carestream health.

• Brand Name: DRX MOBILE REVOLUTION SYSTEM
• Type of Device: DRX REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH; 150 verona st; rochester NY 14608
• MDR Report Key: 7657331
• MDR Text Key: 112994221
• Report Number: 1317307-2018-00003
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K120062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other