MAUDE Adverse Event Report: NEW PRODUCT DEVELOPMENT, INC TRILLIUM 5000 HOLTER ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)

Model Number 5900

Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  malfunction  

Event Description

All holter devices were displaying error code 602. All holters failed to operate starting (b)(6) 2020. After many investigations and followup with the manufacturer, there was an issue with their system identifying year 2020, which caused all systems to fail. Manufacturer response for long term recorded, trillium (per site reporter). On (b)(6) manufacturer identified the bug and will be issuing a software update to fix it. We have no eta for the fix.

• Brand Name: TRILLIUM 5000 HOLTER
• Type of Device: ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
• Manufacturer (Section D): NEW PRODUCT DEVELOPMENT, INC; 6700 old collamer road; east syracuse NY 13057
• MDR Report Key: 9805141
• MDR Text Key: 182556190
• Report Number: 9805141
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/09/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 5900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage