MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. CARESTREAM DRX-MOBILE RETROFIT KIT; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Device Problem Radiation Output Problem (4026)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 09/04/2020

Event Type  malfunction  

Event Description

Exposure could not be made resulting in getting another machine resulting in possible re-exposure to patient.

• Brand Name: CARESTREAM DRX-MOBILE RETROFIT KIT
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; 1049 west ridge road; rochester NY 14615
• MDR Report Key: 10655620
• MDR Text Key: 210613331
• Report Number: 10655620
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2020
• Date Report to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA