MAUDE Adverse Event Report: GE HEALTHCARE JAPAN CORPORATION OPTIMA 660; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPG52

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

Patient Problem Laceration(s) (1946)

Event Date 03/19/2022

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 a patient's elbow penetrated the scan window during a ct scan; sustaining a cut that was treated by suturing.

Manufacturer Narrative

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 HEALTHCARE JAPAN CORPORATION; 7-127 asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• Manufacturer (Section G): GE HEALTHCARE JAPAN CORPORATION; 7-127 asahigaoka 4-chome; hino-shi 191-8 503; JA 191-8503
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 14120477
• MDR Text Key: 294589427
• Report Number: 9612283-2022-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110227
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSPG52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 60 KG