MAUDE Adverse Event Report: GENERAL ELECTRIC GE OPTIMA; X-RAY MACHINES

Catalog Number XR220AMX

Device Problems Premature Discharge of Battery (1057); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

The ge portable optima device has several power failures.The battery will die without warning in the middle of cases.I have two brand new units and they both have behaved this way in a little over a year.Ge willingly admits to issues with the way the machine powers on.

• Brand Name: GE OPTIMA
• Type of Device: X-RAY MACHINES
• Manufacturer (Section D): GENERAL ELECTRIC
• MDR Report Key: 6705796
• MDR Text Key: 79925785
• Report Number: MW5070913
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XR220AMX
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other