MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DEFINIUM 8000; SYSTEM, X-RAY, STATIONARY

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

The incident occurred when trying to line up the x-ray tube to the wall bucky and they failed to line up.No x-ray was taken.Was unable to perform the exam because to equipment failed to line up.Patient had to go up to the cancer center.

• Brand Name: DEFINIUM 8000
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 8645217
• MDR Text Key: 146218276
• Report Number: 8645217
• Device Sequence Number: 1
• Product Code: KPR
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA