MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING NM/CT 830; SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION

Model Number NMH972

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

Udi : (b)(4).Legal manufacturer: hcs haifa fi - 4 hayozma st.Israel tirat hacarmel hefa, 30200.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient sustained a broken toe from contact with the detector while it was being repositioned.

Manufacturer Narrative

It was reported that during a scan a patient sustained a fractured toe.The patient was placed with their feet protruding beyond the limits of the table, and the technologist initiated the transition to mode (detectors positioned opposed to each other) and left the room while the detector was in motion.The system's detector contacted the patient's right toe.Investigation concluded there was no malfunction of the system and the operator failed to follow user manual instructions.The following use error root causes were identified: 1) did not position the patient correctly 2) did not ensure obstruction free area before and during movement 3) left the patient unsupervised.The design's residual risk has been determined to be afap and no mitigations are available to significantly reduce the risk further.Gehc will continue to trend similar events.

• Brand Name: NM/CT 830
• 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: 18222091
• MDR Text Key: 329194259
• Report Number: 9613299-2023-00010
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K111445
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NMH972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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): Other
• Patient Sex: Male