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

Model Number DRX REVOLUTION 3543

Device Problems Retraction Problem (1536); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

Tube head extension would not retract to normal travel position with out being forced.Vendor technician repair required completed device returned to service.

• Brand Name: DRX REVOLUTION MOBILE X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): CARESTREAM HEALTH, INC.; 150 verona street; rochester NY 14608
• MDR Report Key: 15492317
• MDR Text Key: 300653126
• Report Number: 15492317
• Device Sequence Number: 1
• Product Code: IZL
• 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: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRX REVOLUTION 3543
• Device Catalogue Number: 8618894
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1