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

Model Number CSRV29

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Udi : 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, when exiting the bore, the patients hand was injured by contact under the cradle and treated with four stitches.

Manufacturer Narrative

The customer reported that after the scan, the patients hand was draped over the side of the table and no positioning strap was used (which is recommended per the user manual).When the cradle moved out of the gantry and back to home position, the hand was pinched and injured under the cradle.The patient received 4 stitches.Ge healthcare's (gehc) investigation confirmed that the table was not damaged and it was manufactured per specification.The primary root cause of the reported issue is use error.

• Brand Name: REVOLUTION CT
• 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: 16940990
• MDR Text Key: 315319357
• Report Number: 9612283-2023-00002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K163213
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSRV29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2019
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 57 KG