MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for NASIFF ASSOCIATES EKG SOFTWARE manufactured by Nasiff Associates, Inc..
[134707577]
I am a cardiologist who interprets ekgs across the country. I have been noticing significant errors in the calculations of nasiff ekg software for months resulting is significant errors in its ability to analyze ekg durations which affect the ability to accurately interpret. I have communicated directly with the company on multiple occasions, sending in sample tracing demonstrating obvious errors. I have even sent in identical ekgs from the same patient demonstrating vastly different automatic measurement between the two. These errors can easily lead to misdiagnosis of ekgs. The company has not provided any explanation as to why their software is producing so many errors. Given that their software is used across the country, i believe it may well be leading to errors in patient care. The company has stated that they are looking into the matter, but after nearly two months, still have not provided any answers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083438 |
| MDR Report Key | 8286340 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-25 |
| Date Added to Maude | 2019-01-29 |
| 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 |
| 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 | NASIFF ASSOCIATES EKG SOFTWARE |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2019-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NASIFF ASSOCIATES, INC. |
| Manufacturer Address | NEW YORK NY 13036 US 13036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |