MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN PLANNING LAPTOP WORKSTATION

Model Number	SYS-0185
Medical Device Problem Codes	Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A veran territory manager/sales representative was on-site when the following event occurred.During the case set up, the sales representative tried to export the plan from the sys-0185 (spinplanning laptop workstation) to the sys-4000 (spin thoracic navigation system, 120v, 60hz) over spin link, but the spin link transfer had a yellow caution symbol.Troubleshooting was performed with veran technical support (vsupport), but the spin link connection would not work.The sales representative then tried to transfer the plan over a universal serial bus (usb), but he continued to receive a message that the data could not be uploaded.After trying two more usb's, the sales representative discovered that the information technology (it) department at this site blocks usb use, and that a special encrypted usb was needed.The doctor decided to move forward with the procedure using fluoroscopy, in conjunction with the already-planned radial endobronchial ultrasound (ebus).There was a 1-hour delay during troubleshooting, during which the patient was under anesthesia.The procedure was successfully completed.Further follow-up was performed, and the nurse manager confirmed there was no harm to the patient, other than being under anesthesia for a prolonged period of time.After the case, the sales representative worked with the hospital's it department.They performed troubleshooting for the spin link and found that the ip addresses assigned to the systems were on different networks and this is why spin link was not working.Once this was corrected, the spin link worked as it should.It at the hospital provided the sales representative with an encrypted usb to use in the future.This report is being submitted for the prolonged anesthesia.There was no confirmed malfunction of any veran device.
Additional Manufacturer Narrative
The issues were resolved on-site by correcting the issue with the ip addresses, and by obtaining an encrypted usb.

• Brand Name: SPIN PLANNING LAPTOP WORKSTATION
• Common Device Name: PLANNING LAPTOP
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center dr; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 16970374
• Report Number: 3007222345-2023-00023
• Device Sequence Number: 17505937
• Product Code: JAK
• UDI-Device Identifier: 00815686020033
• UDI-Public: 00815686020033
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SYS-0185
• Device Catalogue Number: SYS-0185
• Device Lot Number: 88250221115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYS-4000 SPIN THORACIC NAVIGATION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male