MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK IQECG

Model Number	1-100-1330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: MIDMARK IQECG
• Common Device Name: MIDMARK IQECG
• Manufacturer (Section D): MIDMARK CORPORATION; 690 knox street, suite 100; torrance CA 90502 1369
• MDR Report Key: 10741824
• Report Number: 2081230-2020-00001
• Device Sequence Number: 3385259
• Product Code: DPS
• UDI-Device Identifier: 00841709100581
• UDI-Public: 00841709100581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1-100-1330
• Device Catalogue Number: 1-100-1330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization