NASIFF ASSOCIATES EKG SOFTWARE

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5083438
MDR Report Key8286340
Date Received2019-01-28
Date of Report2019-01-25
Date Added to Maude2019-01-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNASIFF ASSOCIATES EKG SOFTWARE
Generic NameELECTROCARDIOGRAPH
Product CodeDPS
Date Received2019-01-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNASIFF ASSOCIATES, INC.
Manufacturer AddressNEW YORK NY 13036 US 13036


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.