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 2013-02-14 for DIGITRAK XT HOLTER RECORDER manufactured by Philips Medical Systems.
[3296557]
The customer reported that smoke/odor coming from a digitrak xt holter recorder caused a pt to have a burning sensation in her eyes.
Patient Sequence No: 1, Text Type: D, B5
[10679310]
(b)(4). The customer reported that smoke/odor coming from a digitrak xt holter recorder caused a pt to have a burning sensation in her eyes. Based on the customers problem description this will be considered a reportable event. Philips is in the process of obtaining add'l info concerning this event and the complaint is still under investigation. A final report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2013-00539 |
| MDR Report Key | 3004722 |
| Report Source | 05,06,07 |
| Date Received | 2013-02-14 |
| Date of Report | 2013-01-24 |
| Date Mfgr Received | 2013-01-24 |
| Date Added to Maude | 2013-04-25 |
| 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 | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| 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 | 2013-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-02-14 |