MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL INFINIA; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number NMH922

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

Patient Problem Laceration(s) (1946)

Event Date 09/23/2022

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: (b)(6).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, while servicing the device, a field engineer's hand struck the equipment, causing a laceration that was treated with stitches.

Manufacturer Narrative

Fe was performing a maintenance procedure replacing the radial motor.While working with a second person removing a tight bolt, the employee placed his hand between the gantry and the motor.When the motor was unstuck.He sustained a finger laceration when it struck against the gantry.The injury was treated with stitches.Investigation determined he was not wearing gloves as training instructed.

• Brand Name: INFINIA
• Type of Device: SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION
• Manufacturer (Section D): GE MEDICAL SYSTEMS ISRAEL; functional imaging; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• Manufacturer (Section G): GE MEDICAL SYSTEMS ISRAEL; functional imaging; 4 hayozma st.; tirat hacarmel 30200 ; IS 30200
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 15643574
• MDR Text Key: 302164619
• Report Number: 9613299-2022-00003
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: NMH922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• 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 Sex: Male