MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for DIGITRAK XT manufactured by Philips Medical Systems.
[177581814]
Notes from biomed work order: found device error 602 on display, could not clear it with a battery removal reset. Called philips and discovered this was a global error due to the new year, the 602 error is a firmware error related to the device not correctly interpreting the year 2020 and locking up. Philips is aware of the problem and working to create a resolution for it, when that is completed, i will be notified via e-mail. Team was informed all of the digitrak units are no longer functional until the correction is sent out. Manufacturer response for recorders electronic storage data electrocardiography, digitrak xt (per site reporter) our technician has contact philips per case number [redacted]. No further communication has been sent from philips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9664395 |
| MDR Report Key | 9664395 |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-06 |
| Date of Event | 2020-01-06 |
| Report Date | 2020-01-06 |
| Date Reported to FDA | 2020-01-06 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | DIGITRAK XT |
| Generic Name | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2020-02-04 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |