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	06/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation determined that the veran hardware and software did not cause the delay.The issue was resolved on-site by by correcting the issue with the hospital network and domain, and re-scanning the patient per the veran protocol.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Event or Problem Description
A veran territory manager/sales representative was on-site when the following event occurred.The representative was unable to get into the veran laptop, sys-0185 (spin planning laptop workstation), due to the hospital's information technology (it) security/domain blocking the username and password from working.In addition, the hospital did not order an in-house computed tomography (ct) scan for the patient because they were planning to use ct scans from another facility.The hospital's it staff informed the veran representative that due to the laptop not being used and not having been checked in on the hospital's domain security system in over 60 days, the username and password were deactivated as a security measure.In addition, the ct scans provided by the other facility were insufficient for the veran scan protocol parameters.Once they were able to log on to the laptop and the patient was re-scanned per veran protocol, the scans were able to be uploaded to the laptop and they were able to proceed and collect samples, as planned.There was no patient injury or impact due to the issues; however, the patient was under anesthesia for an additional 90 minutes while the it issues were being addressed and the patient was being re-scanned at the user facility.There was no malfunction of the veran laptop.This event is being reported due to the 90-minute delay during which the patient was under anesthesia.

• 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
• MDR Report Key: 17191909
• Report Number: 3007222345-2023-00031
• Device Sequence Number: 7333975
• Product Code: JAK
• UDI-Device Identifier: 00815686020033
• UDI-Public: 00815686020033
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown