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 2009-12-22 for DIGITRAK PLUS 24 HOUR HOLTER RECORDER M3731A manufactured by Philips Medical Systems.
[1316135]
The customer reported that they loaded 3 different patient files from 3 different recorders where all three files appear to be the same.
Patient Sequence No: 1, Text Type: D, B5
[8490719]
The customer reported that they loaded 3 different patient files from 3 different recorders where all three files appear to be the same. On the same day, the philips response center helped troubleshoot the issue with the customer. The customer stated that they had holter application set to load an ecg file rather than download the ecg file from the recorder. This accounts for the customer reported problem. The philips response center explained to the customer the cause of the problem. The customer is now aware of their mistake. We will consider this a user error where the same file was loaded multiple times, and where there was confusion about the source of the files.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2009-02021 |
| MDR Report Key | 1574373 |
| Report Source | 05,06,07 |
| Date Received | 2009-12-22 |
| Date of Report | 2009-12-01 |
| Date Mfgr Received | 2009-12-01 |
| Date Added to Maude | 2010-05-28 |
| 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 | DIGITRAK PLUS 24 HOUR HOLTER RECORDER |
| Product Code | MWJ |
| Date Received | 2009-12-22 |
| Model Number | M3731A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2009-12-22 |