MAUDE Adverse Event Report: CARESTREAM HEALTH INC. DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)

Catalog Number 8118894

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Carestream health has evaluated the device and determined there was no device malfunction, and system is performing as designed and intended.Although it cannot be confirmed due to the lapse of time between incident and the actual report, csh and the customer site suspect that this incident is most likely due to user error while driving the system with one hand.The fe communicated to the operators to use both hands, per the instructions for use (ifu), while driving the system.He also demonstrated the use and release of the deadman switch to mitigate issues.Site responded that they would be retraining techs.Additionally, the site had previously started using rubber door stops to hold open doors when driving the drx revolution through doorways to mitigate these types of incidents.Carestream has completed this investigation.

Event Description

On 03-may-2022, carestream health (csh) was informed, via email, of an incident related to the drx-revolution plus mobile x-ray system which occurred at (b)(6) on (b)(6) 2021 (as reported by site - actual day unknown).Per carestream health service personnel investigation which confirmed the following: the system in "as found" condition: normal working conditions with no issues.At the time of the incident, (b)(6) 2021 - exact date is unknown as the incident was not reported to csh at that time, the system was being driven by a site tech.Per the report, the technologist alleged they was reversing the mobile out of an inpatient room at (b)(6).As the technologist was turning the mobile, it swung quickly and trapped her leg between the wall and the portable.As the mobile had collided with something, it was difficult to move it and her leg was crushed for a few seconds.She had bruising at the time and a few months later, she was experiencing intermittent pain when walking/standing behind her knee in the place it was pinned.She went to physio, and they stated it was an injury to her hamstring.She received treatment by physio and the pain subsided.There was no patient involvement.

• Brand Name: DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)
• Type of Device: DRX-REVOLUTION MOBILE X-RAY SYSTEM (PLUS)
• Manufacturer (Section D): CARESTREAM HEALTH INC.; 150 verona street; rochester NY 14608
• Manufacturer (Section G): CARESTREAM HEALTH INC.; 1049 ridge road west; rochester NY 14615
• Manufacturer Contact: nancy mejias ; 150 verona street; rochester, NY 14608 ; 5856278533
• MDR Report Key: 14507768
• MDR Text Key: 292701741
• Report Number: 1317307-2022-00008
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 60889978618897
• UDI-Public: 0160889978618897
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8118894
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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