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U.S. Department of Health and Human Services

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

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NEW PRODUCT DEVELOPMENT, INC TRILLIUM 5000 HOLTER ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) Back to Search Results
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.
 
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Brand NameTRILLIUM 5000 HOLTER
Type of DeviceELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS)
Manufacturer (Section D)
NEW PRODUCT DEVELOPMENT, INC
6700 old collamer road
east syracuse NY 13057
MDR Report Key9805141
MDR Text Key182556190
Report Number9805141
Device Sequence Number1
Product Code MWJ
Combination Product (y/n)N
Number of Events Reported1
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 Received03/09/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2020
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer03/09/2020
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

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