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 2009-10-02 for DIGITRAK XT HOLTER RECORDER manufactured by Philips Medical Systems.
[1235857]
The customer reported a holter recording had shown a repetitive waveform that did not look like noise. It only occurred on this recorder.
Patient Sequence No: 1, Text Type: D, B5
[8366251]
The customer reported a holter recording had shown a repetitive waveform that did not look like noise. It only occurred on this recorder. The factory has not yet received the device for eval, and the complaint is still being investigated. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2009-01440 |
| MDR Report Key | 1490834 |
| Report Source | 05,06,07 |
| Date Received | 2009-10-02 |
| Date of Report | 2009-09-02 |
| Date Mfgr Received | 2009-09-02 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2009-10-07 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 0 |
| 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 XT HOLTER RECORDER |
| Product Code | MWJ |
| Date Received | 2009-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2009-10-02 |