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

Model Number CSPL02

Device Problem Use of Device Problem (1670)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: (b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that during a scan, a patient kneed the mylar and was treated with stitches.

Manufacturer Narrative

The root cause was determined to be unintended user error, i.E.The patient was not kept sufficiently still during scanning; allowing the patient to deflect the mylar window; contacting the collimator during rotation.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.; bld 3 1 yongchang north road; beijing economic and tech; beijing 10017 6; CH 100176
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; bld 3 1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 15555567
• MDR Text Key: 301345099
• Report Number: 9613445-2022-00006
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• 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