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

Model Number	SYS-0185
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A veran representative was on-site when the following event occurred.The sys-0185 (spin planning laptop workstation) was described as running slow during a procedure.After troubleshooting steps were performed, it was observed that the central processing unit (cpu) was functioning at a low percentage.The procedure was able to be completed after a 45-minute delay.There was no impact on the patient due to the extended procedure time.Although there was no patient injury or impact, this event is being reported due to the 45-minute delay while the patient was under anesthesia.
Additional Manufacturer Narrative
The planning laptop was replaced with a newer model at the facility to address the issue.D9:the device is not available for evaluation, as it was scrapped upon return to veran.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• 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: 17186946
• Report Number: 3007222345-2023-00030
• Device Sequence Number: 20456744
• Product Code: JAK
• UDI-Device Identifier: 00815686020033
• UDI-Public: 00815686020033
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 01/29/2021
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2018
• 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