MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC REVOLUTION EVO; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPL20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

Udi : (b)(4).Legal manufacturer: (b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.

Event Description

It was reported that while servicing the device, an fe sustained an electrical burn to the hand.

Manufacturer Narrative

An in-house fe (ihfe-non ge fe) was troubleshooting a customer reported communication issue on the ct gantry.During troubleshooting of the communication problem the ihfe improperly reattached the receiver.He then replaced the das control board which fixed the original communication issue, however still found the system to be down (unknowingly because of the improperly seated receiver).

• Brand Name: REVOLUTION EVO
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd; waukesha WI 53188
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 15132035
• MDR Text Key: 296908907
• Report Number: 2126677-2022-00012
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CSPL20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male