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 turns on and turns off after a few seconds despite changing batteries.The patient had no adverse event or reaction resulting from this problem.
Additional Manufacturer Narrative
The device was not returned therefore the problem statement/complaint could not be confirmed.

• Brand Name: HOMECG
• Common Device Name: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
• Manufacturer (Section D): LOHMAN TECHNOLOGIES, LLC; n27 w23953 paul rd, st 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: 23791391
• Report Number: 3012267350-2025-00016
• Device Sequence Number: 12190712
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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
• Device Model Number: V2.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown