MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA 660; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPL02

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

Patient Problem Abrasion (1689)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient penetrated the scan window during a ct scan; sustaining an abrasion.While there was no serious injury, penetration of the scan window during scanning could result in a serious injury.Serious injury is not likely since the scan window itself is designed to distance the patient from rotating parts while affording diagnostic image quality.Serious injury is not the normally anticipated outcome associated with patient motion issues.

Manufacturer Narrative

While there was no serious injury, penetration of the scan window during scanning could result in a serious injury.The root cause was determined to be unintended user error, i.E.The operator did not properly position and strap the patient securely for the procedure.The user manual provides instructions on appropriate patient positioning.

• Brand Name: OPTIMA 660
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no1 yongchang n rd; beijing 10017 6; CH 100176
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no1 yongchang n rd; beijing 10017 6; CH 100176
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 12676874
• MDR Text Key: 282347114
• Report Number: 9613445-2021-00004
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSPL02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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