MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for PHILIPS 860322 manufactured by Philips Medical Systems.
[175678755]
Philips has determined that an issue with the firmware results in abnormal device behavior associated with the recorder's internal real-time clock. This manifests itself when the year rolls over from 2019 to 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610707 |
| MDR Report Key | 9610707 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-08 |
| Report Date | 2020-01-08 |
| Date Reported to FDA | 2020-01-08 |
| Date Reported to Mfgr | 2020-01-21 |
| Date Added to Maude | 2020-01-21 |
| 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 | 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 | PHILIPS |
| Generic Name | ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2020-01-21 |
| 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 ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |