MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-09-25 for ZYMED HOLTER SOFTWARE 860292 manufactured by Philips Medical Systems.
[1178418]
In 2008, the customer reported that the ecg data that was transmitted to the holter application did not match what was being displayed by the patient monitoring pic (iic) philips information system.
Patient Sequence No: 1, Text Type: D, B5
[8367892]
In 2008, the customer reported that the ecg data that was transmitted to the holter application did not match what was being displayed by the patient monitoring pic (iic) philips information system. In december of 2008, philips evaluated data provided by the customer and determined that there was a malfunction, where the time stamps on the exported holter ecg file did not match the screen capture of the pic (iic) provided by the customer. The data did not appear to be missing or altered in any other way. Note that no device was returned to philips, but sample ecg filed were returned to philips for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2009-01229 |
| MDR Report Key | 1489015 |
| Report Source | 05,06,07 |
| Date Received | 2009-09-25 |
| Date of Report | 2008-10-14 |
| Date Mfgr Received | 2008-10-14 |
| Date Added to Maude | 2009-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATTI NILL |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786593769 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYMED HOLTER SOFTWARE |
| Product Code | MLO |
| Date Received | 2009-09-25 |
| Model Number | 860292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-09-25 |