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 2011-03-21 for ZYMED HOLTER SOFTWARE 860292 manufactured by Philips Healthcare.
[16490346]
(b)(4). It was reported that another pt's data had merged into this pt's report. There was no report of adverse pt impact. Philips evaluated and confirmed that the customer is using an unsupported 3rd party software (filemaker). The customer was informed that philips does not support filemaker. Philips holter instructions for use, chapter a section 1 "exporting the scan" provides details on the supported export formats used. We are not considering this a malfunction of the holter application, but a use issue where the customer is using an unsupported software database to import ecg files into.
Patient Sequence No: 1, Text Type: N, H10
[16535408]
It was reported that another pt's data had merged into this pt's report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2011-00764 |
| MDR Report Key | 2031746 |
| Report Source | 05,06,07 |
| Date Received | 2011-03-21 |
| Date of Report | 2011-02-22 |
| Date Mfgr Received | 2011-02-22 |
| Date Added to Maude | 2011-04-04 |
| 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 | CHRISTIE DESCHENES |
| Manufacturer Street | 3000 MINUTEMAN RD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZYMED HOLTER SOFTWARE |
| Product Code | MLO |
| Date Received | 2011-03-21 |
| Model Number | 860292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-21 |