FDA Adverse Event
Malfunction
Summary report: N
HOMECG+
MDR report key: 23043096
·
Received September 12, 2025
Report
- Report Number
- 3012267350-2025-00013
- Event Type
- Malfunction
- Date Received
- September 12, 2025
- Report Date
- September 12, 2025
- Manufacturer
- LOHMAN TECHNOLOGIES, LLC
- Product Code
- DXH
- UDI-DI
- 00560003939734
- PMA / PMN Number
- K052767
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE APPEARED TO BE OPERATING ON AN OLDER FIRMWARE VERSION WHICH WAS CAUSING ISSUES WHEN ATTEMPTING TO TAKE SCANS. AFTER DELIVERY OF THE DEVICE WITH UPDATED FIRMWARE, THE USER WAS ABLE TO SUCCESSFULLY OBTAIN SCANS. ADDITIONALLY, THE USER RECEIVED WRIST ELECTRODES.
Description of Event or Problem · 0
THE USER REPORTS CHALLENGES WITH LOST CONTACT WHEN PLACING THUMBS ON THE ELECTRODES. THE USER HAD NO ADVERSE EVENT OR REACTION FROM THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2070587 | HOMECG+ | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | DXH | LOHMAN TECHNOLOGIES, LLC | V2.0 | 2021 - 16828 | 00560003939734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |