MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for DIGITRAK XT 860322 manufactured by Philips Medical Systems.
[173703990]
Upon setting up holter testing, an error message (602) was displayed and staff were unable to program device to apply on patient for testing. Manufacturer response for holter monitor recorder, philips (per site reporter). The hospital it department is working with the manufacture. It is suspected that this problem is related to the date of 2020 and is a nationwide problem. No further guidance, as of yet from, the manufacture. We will continue to work with philips until a resolution has been identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9550889 |
| MDR Report Key | 9550889 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2020-01-02 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2020-01-06 |
| Date Added to Maude | 2020-01-06 |
| 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 | RISK MANAGER |
| 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 | DIGITRAK XT |
| Generic Name | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2020-01-06 |
| Model Number | 860322 |
| Catalog Number | 860322 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |