MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC OPTIMA XR220; SYSTEM, X-RAY, MOBILE

Model Number 5555000-5

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported by ge service personnel that as a ge service representative was replacing the systems batteries with the system covers removed, an electrical arc flash occurred resulting in a cable starting on fire.The fire then burned approximately one to two minutes before the hospitals fire brigade extinguished the thermal event.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare?s investigation has been completed and it was confirmed the batteries cable assembly and system batteries were both partially burned but since the burned components were immediately disposed of, the root cause of the thermal event could not be confirmed.The most likely cause is a service handling error that resulted in one of the cables accidently coming off from the connector resulting in a short with the other terminal in the connector.This caused a voltage arc and short circuit within the cable generating a thermal event.To correct this issue, the field service engineer replaced both the batteries as well as the batteries cable assembly, tested and confirmed device functionality and the device was turned back over to the user for clinical use.No further actions are needed at this time.

• Brand Name: OPTIMA XR220
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53188-1696
• MDR Report Key: 5751926
• MDR Text Key: 48252051
• Report Number: 2126677-2016-00008
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K103476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5555000-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1