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Model Number 1-100-1325
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Myocardial Infarction (1969)
Event Date 01/05/2018
Event Type  Injury  
Event Description

(b)(4), (b)(6) 2018 for the customer report of ecg report shows normal during a heart attack the mdr/cmdr reporting investigation decision is no, and the mdr decision tree indicates no pt injury occurred on (b)(6) 2018 while an engineering report dated (b)(4) 2018 indicates the pt was treated with having a stent put in. Mfg review "st changes were perhaps suggestive of myocardial ischemia with significant st segment elevation. However, in order for it to be classified as "impending myocardial infarction' or 'ischemia', very specific patterns need to be identified. While this case was perhaps close enough to those criteria, the physician could have been advised to take a closer look (with an interpretation such as "pattern partially suggestive of acute myocardial ischemia) rather than call it 'normal'. Midmark's ecg system is responsible for producing a reliable and accurate waveform to the clinical team to interpret, first and foremost. In cases where an internal firmware / hardware error that causes the waveform morphology to aberrant. I am much more concerned as the clinician cannot interpret the clinical situation accurately in those cases. In this case, the waveform is not in doubt, only the interpretation we provide. But even the interpretation is not necessarily 'wrong'. In a purely classical and binary sense, this tracing did not fully qualify this pt as meeting the criteria for ischemia. "our ecg device provides the physician ecg waveform and ecg measurements / interpretation. I agree with you that reliable and accurate waveform is the most important. To ensure that the ecg device provides reliable and accurate ecg waveform, the ecg design was tested according aam ec11 (for diagnostic ecg) and other appropriate standards and each ecg device is qc tested in house before it is shipped out. There is a small chance that a component failure may cause the inaccurate ecg waveform. This situation should already be considered in ecg risk analysis. For ecg measurements and interpretation, there was no standard available when we released our ecg software 20 years ago. We validated the ecg measurements with cse ecg database. The ecg interpretation algorithm was also validated with some ecg database and some cardiologists. The "accuracy" of the interpretation usually is about 70-80%. Therefore, as indicated in ecg ifu, the interpretation should always be reviewed / confirmed by physician. " in conclusion, mfg may have admitted the waveforms were indicative of ischemic event in pt, but interpretation indicated pt was ok, which is not in line with ifu (dr must review waveform before assessing pt). Pt later suffered a heart attack and had a stent placed. This was not reported as an mdr to fda. Fda safety report id# (b)(4).

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Brand NameIQECG
Manufacturer (Section D)
MDR Report Key8802873
MDR Text Key151701017
Report NumberMW5088200
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 07/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device MODEL Number1-100-1325
Device Catalogue Number1-100-1325
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
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?
Type of Device Usage

Date Received: 07/17/2019 Patient Sequence Number: 1