MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC. OPTIMA; SYSTEM, X-RAY, MOBILE

Model Number XR220AMX

Device Problem Device Inoperable (1663)

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

Event Date 01/10/2017

Event Type  Injury  

Event Description

A portable chest x-ray was requested and could not get portable chest x-ray to work.There was a delay in the procedure.The patient was taken to x-ray department via stretcher.Unknown if machine was reported having issues.

• Brand Name: OPTIMA
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC.; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 6386917
• MDR Text Key: 69362412
• Report Number: 6386917
• Device Sequence Number: 1
• Product Code: IZL
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XR220AMX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/02/2017
• Event Location: Other
• Date Report to Manufacturer: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1