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

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.

• Brand Name: NASIFF ASSOCIATES EKG SOFTWARE
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): NASIFF ASSOCIATES, INC.; new york NY 13036
• MDR Report Key: 8286340
• MDR Text Key: 134707577
• Report Number: MW5083438
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• 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 Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1