MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for HOLTER manufactured by Philips Medical Systems.
[108920164]
Patient Sequence No: 1, Text Type: N, H10
[108920165]
The nurse placed a 24 hour holter on patient in clinic. The holter was returned and when the medical assistant went to download the information from the holter, there was no data on the device. The nurse attempted to download the information as well and had the same result. The nurse notified the electrophysiology lab and notified the ordering physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7534206 |
| MDR Report Key | 7534206 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-04-05 |
| Report Date | 2018-05-03 |
| Date Reported to FDA | 2018-05-03 |
| Date Reported to Mfgr | 2018-05-03 |
| Date Added to Maude | 2018-05-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLTER |
| Generic Name | ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2018-05-22 |
| ID Number | 091101 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |