MAUDE Adverse Event Report: ALPHA OMEGA ENGINEERING LTD. NEURONAV; LNTRAOPERATIVE NEUROPHYSIOLOGICAL RECORDING AND STIMULATING DEVICE

Model Number 14

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

The neuronav "system" sn (b)(6) was supplied to the (b)(6) hospital in 2017, it left alpha omega's facility on august 14th 2017.This system last passed preventive "maintenance" on october 18th 2021 before this malfunction, prior to that it passed preventive "maintenance" each year.Following this malfunction, this neuronav main unit was repaired and upgraded to higher device version at alpha omega facility, and shipped back to usa on dec 20, 2022.The system was shipped back to the hospital on jan 31, 2023.Following "receiving" the unit, the hospital "received" case support on april 17th 2023 by alpha omega representative, and reported "successful" procedure.

Event Description

The neuronav hdd laptop failed, so the system laptop failed to boot, an alternative neurosmart system from another hospital was borrowed, so the hospital proceeded with the surgery.

• Brand Name: NEURONAV
• Type of Device: LNTRAOPERATIVE NEUROPHYSIOLOGICAL RECORDING AND STIMULATING DEVICE
• Manufacturer (Section D): ALPHA OMEGA ENGINEERING LTD.; hamerkava st.6, tsiporit indus; nof hagalil (nazareth illit), 17890 62; IS 1789062
• MDR Report Key: 17161253
• MDR Text Key: 317720859
• Report Number: 3001610756-2023-00001
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 07290014954052
• UDI-Public: 07290014954052
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14
• Device Catalogue Number: 700-006002-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female