MAUDE Adverse Event Report: ABBOTT VASCULAR ULTIRI MEASUREMENT SYSTEM; PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER

Catalog Number 600160796

Device Problems Application Network Problem (2879); Computer System Security Problem (2899)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that when preparing the ultiri measurement system, error 1923 occurred when powering the system off and on again.The network cable was disconnected and the home screen was accessed.However, error code 4401 was then displayed with the following error message: "unauthorized activity was detected and prevented by the application control system." a decision was made not to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.A potential cyber security and software/bug issue is suspected and field service is pending.No additional information was provided.

• Brand Name: ULTIRI MEASUREMENT SYSTEM
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18616531
• MDR Text Key: 334227502
• Report Number: 2024168-2024-01270
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 05415067037626
• UDI-Public: 05415067037626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

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 Catalogue Number: 600160796
• Device Lot Number: 19445542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1