MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL DISCOVERY NM 530C; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number NMH317

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported that a technologist sustained a facial injury that was treated with sutures as a result of manually advancing the system while another technologist engaged the drive.

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.

Manufacturer Narrative

It was reported that a technologist sustained a facial injury that was treated with sutures as a result of manually advancing the system while another technologist engaged the drive.The tech was retrained on the proper use of the manual tool and the correct way to release the patient in emergency situations.

• Brand Name: DISCOVERY NM 530C
• 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: 14310068
• MDR Text Key: 290964774
• Report Number: 9613299-2022-00001
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080124
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NMH317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2012
• 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: Female