MAUDE Adverse Event Report: GEHC HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA 580; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPE76

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

Udi : (b)(4).Legal manufacturer: hcs beijing - west area of building no.3, no.1 yongchang north road, beijing economic and technological development area china beijing beijing, 100176.Ge healthcare's investigation 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

It was reported that, while performing maintenance training for two new hires in his department, an inhouse field engineer manually rotated the gantry and pinched his hand; sustaining a puncture.Medical treatment included five stitches.

Manufacturer Narrative

It was reported that during maintenance training, a customer's inhouse field engineer sustained a hand injury that was treated with stitches.Investigation revealed that he was teaching two new hires, and he implemented the teaching according to the standard process.However, he was not paying attention when he rotated the gantry while resting his hand inside the gantry.The service manual states that personal protective equipment needs to be worn, but he was not wearing safety gloves.The service manual states "never put any part of your body into the gantry, unless the gantry is locked." but he did not follow this instruction.Investigation and risk assessment have concluded that there is no need for capa because the design's residual risk has been determined to be afap and no mitigations are available to significantly reduce the risk further.Gehc will continue to trend similar events.

• Brand Name: OPTIMA 580
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GEHC HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3; no.1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer (Section G): GEHC HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3; no.1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 18020756
• MDR Text Key: 326717777
• Report Number: 9613445-2023-00005
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CSPE76
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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 Sex: Male