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

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

The investigation into this incident has shown that this is a case of user misuse.The technologist was about to place a lead shield (not part of the device) into the bin that is intended for storage of detectors.When the technician released the shield, it became lodged between the base of the bin and the drive bar.This engaged the drive handle resulting in backwards motion and the contact with the technologist.The customer site has been advised by carestream that the bin is specifically for storage of detectors and it should not be used to store other items.Carestream health (csh) considers this incident resolved and there is no further action required on the part of csh.

Event Description

The hospital reported that a drx-revolution ran over a technologist's foot, resulting in several broken toes.The revolution moved when a lead shield that was placed in the revolution bin tipped forward and struck the drive handle causing the device to move backward, making contact with the technologist.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Type of Device: DRX REVOLUTION
• Manufacturer (Section D): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC; 150 verona st; rochester NY 14608
• Manufacturer Contact: michael callery ; 150 verona st; rochester, NY 14608 ; 5856278230
• MDR Report Key: 5854766
• MDR Text Key: 51412852
• Report Number: 1317307-2016-00006
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041763
• 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: 08/08/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other