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.
[3376830]
The customer reported that a pt returning a digitrak xt holter recorder stating that she was burned by the monitor while wearing it.
Patient Sequence No: 1, Text Type: D, B5
[10541971]
(b)(4): the customer reported that a pt returning a digitrak xt holter recorder stating that she was burned by the monitor while wearing it. She also claimed that she was using heated seats in her car and that the seat also sustained a burn hole. 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 | 1218950-2013-00538 |
| MDR Report Key | 3004721 |
| 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 |