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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NASIFF ASSOCIATES, INC. NASIFF ASSOCIATES EKG SOFTWARE ELECTROCARDIOGRAPH

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NASIFF ASSOCIATES, INC. NASIFF ASSOCIATES EKG SOFTWARE ELECTROCARDIOGRAPH Back to Search Results
Device Problem Computer Software Problem (1112)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

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.

 
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Brand NameNASIFF ASSOCIATES EKG SOFTWARE
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
NASIFF ASSOCIATES, INC.
new york NY 13036
MDR Report Key8286340
MDR Text Key134707577
Report NumberMW5083438
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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