MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK IQECG

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.

• Brand Name: MIDMARK IQECG
• Type of Device: MIDMARK 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 Key: 10741824
• MDR Text Key: 213250281
• Report Number: 2081230-2020-00001
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00841709100581
• UDI-Public: 00841709100581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103640
• Number of Events Reported: 1
• 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 Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization