MAUDE Adverse Event Report: LOHMAN TECHNOLOGIES, LLC HOMECG+; TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Model Number	V2.0
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device appeared to be operating on an older firmware version which was causing issues when attempting to take scans.The device was tested, then updated to latest firmware and was found to be functional.After delivery of a new device with updated firmware, the patient was able to successfully obtain scans.
Event or Problem Description
The patient reports receiving an unable to analyze result the majority of the time when attempting readings.When reviewing data uploaded to the cloud, there are inconsistencies in the data available.The patient had no adverse event or a reaction resulting from this problem.

• Brand Name: HOMECG+
• Common Device Name: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): LOHMAN TECHNOLOGIES, LLC; n27 w23953 paul rd; ste 204; pewaukee WI 53072
• Manufacturer (Section G): VERSA ELECTRONICS; 3943 quebec ave n; minneapolis MN 55427
• Manufacturer Contact: jason dvorak ; n27 w23953 paul rd; ste 204; pewaukee, WI 53072 ; 2622275066
• MDR Report Key: 22873951
• Report Number: 3012267350-2025-00001
• Device Sequence Number: 10371181
• Product Code: DXH
• UDI-Device Identifier: 00860003939734
• UDI-Public: (01)00860003939734
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: Lay User/Patient
• Device Model Number: V2.0
• Device Lot Number: 2021 - 168283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female