MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY RF180; SYSTEM, X-RAY, FLUOROSCOPIC

Device Problem Use of Device Problem (1670)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

Ge healthcares investigation into the reported event has been initiated and is ongoing.A follow-up report will be submitted when the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2023, the ge healthcare (gehc) field service engineer (fse) was performing generator calibrations during the installation of a discovery rf180 system.As the fse was walking back to the generator from the operators console, they tripped, and their right forearm came into contact with an energized part within the generator cabinet.The gehc fse was diagnosed with a right forearm burn that required surgical intervention.The discovery rf180 system is manufactured by general medical marate and gehc is considered the importer of this system.

Manufacturer Narrative

Ge healthcare's investigation has been completed and the cause of the ge healthcare field service engineer's (fe) injury was determined to be a service error.During the installation of a discovery rf180 system, the fe accidently tripped over his feet which resulted in him coming into contact with live circuits within the generator cabinet.Review of the installation procedure identified the fe did not reinstall the front cover before proceeding with servicing as instructed in the manual.Corrections for this event included updated service training to reinforce appropriate generator cover management along with the communication of the updated procedure to all required fes through a safety alert.No further actions are needed.

• Brand Name: DISCOVERY RF180
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC
• 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: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53188
• MDR Report Key: 17230579
• MDR Text Key: 318139846
• Report Number: 2126677-2023-00003
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White