MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK DIGITAL ECG; ELECTROCARDIOGRAPH

Model Number	1-100-1550
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that high heart rates from 7 ecg devices were shown on the ecg reports.The following serial numbers are: (b)(6) the customer stated that the doubling of heart rates were seen on a single patients ecg report.A patient was prescribed heart medication (cardizem) as their report showed high heart rate.The medication was not consumed by the patient and tachycardia was ruled out by a live holter monitoring device.Technical service reached out to the customer to troubleshoot and was unable to recreate the issue with the ecg units used.There was no patient injury.
Additional Manufacturer Narrative
The customer did receive clinical education after the issue started occurring.A site visit was also made which included a midmark technical service representative, engineers, and a sales representative to help rule out any external variables that could be triggering the issue.Multiple attempts were made by the customer with the help of midmark representatives to recreate the issue.The issue of doubling of the heart rate was unable to be recreated or observed while midmark representatives were on site.
Additional Manufacturer Narrative
It was found that the electronic medical record (emr) system software was opening a second instance of the ecg plug-in software while there was already an instance of the ecg plug-in running in the background.Midmark was able to reproduce the issue in-house and confirm that the doubling of the heart rate was caused by two applications of the ecg plug-in software being opened concurrently.Therefore, it was determined that the emr system opening both instances of the ecg plugin software led to the issue of the heart rate doubling on the display screen.A fix for the ecg plug-in software was created to call out any additional ecg plug-in application being launched and notify the user to prevent an additional instance being opened.Validation and verification testing was completed and the fix was sent out to the customer.
Event or Problem Description
It was reported that high heart rates from 7 ecg devices were shown on the ecg reports.The following serial numbers are: (b)(6).The customer stated that the doubling of heart rates were seen on a single patients ecg report.A patient was prescribed heart medication (cardizem) as their report showed high heart rate.The medication was not consumed by the patient and tachycardia was ruled out by a live holter monitoring device.Technical service reached out to the customer to troubleshoot and was unable to recreate the issue with the ecg units used.There was no patient injury.

• Brand Name: MIDMARK DIGITAL ECG
• Common Device Name: ELECTROCARDIOGRAPH
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: kort fledderjoh ; 60 vista drive; versailles, OH 45380 ; 9375268644
• MDR Report Key: 19234611
• Report Number: 1523530-2024-00004
• Device Sequence Number: 17646286
• Product Code: DPS
• UDI-Device Identifier: 08056732652491
• UDI-Public: 08056732652491
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220526
• Number of Events Summarized: 7
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1-100-1550
• Device Catalogue Number: 4-000-0080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown