MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-09 for ZIO XT PATCH HEARTRATE MONITOR N100A102W manufactured by Irhythm Technologies, Inc..
| Report Number | MW5089679 |
| MDR Report Key | 8982613 |
| Date Received | 2019-09-09 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-09-04 |
| Date Added to Maude | 2019-09-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIO XT PATCH HEARTRATE MONITOR |
| Generic Name | RECORDER, MAGNETIC TAPE, MEDICAL |
| Product Code | DSH |
| Date Received | 2019-09-09 |
| Catalog Number | N100A102W |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRHYTHM TECHNOLOGIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-09-09 |