MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, INC. PRECISION 500D; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number PRECISION 500D

Device Problem Improper Device Output (2953)

Patient Problem No Information (3190)

Event Date 06/16/2017

Event Type  Injury  

Event Description

Risk, rde--- x-ray fluoroscopic room # 2 has a safety issue.In order to get one image the technologist has to expose the patient twice.This does not fall under radiation safety protocols / guidelines put forth by hospital and the state.

• Brand Name: PRECISION 500D
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, INC.; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 6804879
• MDR Text Key: 83100109
• Report Number: 6804879
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRECISION 500D
• Device Lot Number: NOT APPLICABLE
• Other Device ID Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1