MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for TRILLIUM 5000 HOLTER 5900 manufactured by New Product Development, Inc.
[182556190]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9805141 |
| MDR Report Key | 9805141 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-03 |
| Report Date | 2020-01-08 |
| Date Reported to FDA | 2020-01-08 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRILLIUM 5000 HOLTER |
| Generic Name | ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2020-03-09 |
| Model Number | 5900 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW PRODUCT DEVELOPMENT, INC |
| Manufacturer Address | 6700 OLD COLLAMER ROAD EAST SYRACUSE NY 13057 US 13057 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |