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

Model Number	V2.0
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reports that the device powers down despite multiple battery changes.The patient had no adverse event or a reaction resulting from this problem.
Additional Manufacturer Narrative
The batteries in the device were replaced and tested.The device was updated to the latest firmware and was found to be fully functional.Upon testing of other devices with the same issue, a malfunction was identified that prevented the device from turning on when the batteries were low, even though the required voltage to turn the device on was met.

• 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: 22874414
• Report Number: 3012267350-2025-00011
• Device Sequence Number: 10424711
• 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: Health Professional
• Device Model Number: V2.0
• Device Lot Number: 2021 - 168283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Female