MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. CT 750HD; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPH74

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 02/02/2023

Event Type  Injury  

Event Description

It was reported that while servicing the device, the fe sustained a hand injury that was treated with stitches.

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, beijing, china 100176.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.

Manufacturer Narrative

An fe was performing a tube alignment procedure on an hd scanner.During the service procedure the fe was loosening a bolt with a torque wrench when it came loose, and their right hand impacted the frame.The fe sustained an injury to the 5th digit of the right hand which was treated with three sutures.The fe was not wearing protective gloves.There was no malfunction of the system or sharp edge present.The injury was caused by impact force.The fe had completed the required training course which highlights proper ppe (gloves).

• Brand Name: CT 750HD
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3; no.1 yongchang north road; beijing 10017 6; CH 100176
• Manufacturer (Section G): GE 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
• MDR Report Key: 16459338
• MDR Text Key: 310417016
• Report Number: 9613445-2023-00001
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CSPH74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• 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