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 2009-05-08 for DIGITRAK PLUS 48H HOLTER REC MODEL 3100A M3732A manufactured by Philips Healthcare.
[1188206]
The customer disagreed with portions of the holter monitor report; the report stated that the pt's heart rate was >300 beats per minute.
Patient Sequence No: 1, Text Type: D, B5
[8267613]
The customer disagreed with portions of the holter monitor report; the report stated that the pt's heart rate was >300 beats per minute. The factory has not yet received the device for eval, and the complaint is still being investigated. A f/u report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2009-00521 |
| MDR Report Key | 1436194 |
| Report Source | 05,06,07 |
| Date Received | 2009-05-08 |
| Date of Report | 2009-04-09 |
| Date Mfgr Received | 2009-04-09 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2009-10-02 |
| 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 48H HOLTER REC MODEL 3100A |
| Product Code | MWJ |
| Date Received | 2009-05-08 |
| Model Number | M3732A |
| Catalog Number | M3732A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-05-08 |