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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK IQECG

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MIDMARK CORPORATION MIDMARK IQECG Back to Search Results
Model Number 1-100-1330
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 09/25/2020
Event Type  Injury  
Manufacturer Narrative

The file was analyzed by the principle biomedical engineer at midmark. The file was reviewed, and the patient had anterior myocardial infarction which the software had detected. Midmark's physician's guide states: when the evidence of abnormality is on the borderline with signal artifacts, human intelligence is needed. The computer analysis result is just a second opinion for the physicians, it is not a replacement of a trained professionals reading and judgement. Multiple attempts were made by midmark to contact the customer for additional information about the patient.

 
Event Description

It was reported that a misdiagnosis occurred due to a wandering baseline and a p-wave that was missing from the ecg report. The patient suffered a stroke. The customer was contacted and the. Car file was sent. The file was analyzed by the principle biomedical engineer at midmark. The file was reviewed, and the patient had anterior myocardial infarction which the software had detected. Midmark's physician's guide states: when the evidence of abnormality is on the borderline with signal artifacts, human intelligence is needed. The computer analysis result is just a second opinion for the physicians, it is not a replacement of a trained professionals reading and judgement. Multiple attempts were made by midmark to contact the customer for additional information about the patient.

 
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Brand NameMIDMARK IQECG
Type of DeviceMIDMARK IQECG
Manufacturer (Section D)
MIDMARK CORPORATION
690 knox street, suite 100
torrance CA 90502 1369
Manufacturer (Section G)
MIDMARK CORPORATION
690 knox street. suite 100
torrance CA 90502 1369
Manufacturer Contact
ardrena jackson
690 knox street. suite 100
torrance, CA 90502-1369
MDR Report Key10741824
MDR Text Key213250281
Report Number2081230-2020-00001
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK103640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1-100-1330
Device Catalogue Number1-100-1330
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/29/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/27/2020 Patient Sequence Number: 1
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