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

Model Number NMH814

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

Patient Problem Laceration(s) (1946)

Event Date 05/09/2022

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, while unloading him at the end of a scan, a patient sustained a finger injury that was treated with stitches.

Manufacturer Narrative

Customer reported a patient injury.A gastric emptying study was completed successfully with feet first orientation.While patient was being pulled out and table was moving longitudinally outwards, patient raised his finger up and showed it to the technologist that it was bleeding.Technologist stated that there was language barrier and they don't know how it happened and what exactly caused patient injury.Customer requested that the system be thoroughly checked out for safety,.

• Brand Name: MILLENNIUM MG
• 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: 14877046
• MDR Text Key: 295124320
• Report Number: 9613299-2022-00002
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NMH814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2006
• 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