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

Model Number CSPL77

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

Patient Problem Laceration(s) (1946)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Udi : (b)(4).Legal manufacturer: hcs (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 during a training exercise, a field engineer sustained an elbow injury that was treated with stitches.

Manufacturer Narrative

It was reported that during a training exercise, a field engineer sustained an elbow injury that was treated with stitches.The investigation determined that the education/training engineer (ee) was assisting another student in a training class to rotate the ct gantry.Ee exerted a lot of energy to aid rotating the gantry.

• Brand Name: MAXIMA
• 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: 14733737
• MDR Text Key: 294271509
• Report Number: 2126677-2022-00010
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CSPL77
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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