FDA Adverse Event
Malfunction
Summary report: N
HOMECG+
MDR report key: 23791389
·
Received December 12, 2025
Report
- Report Number
- 3012267350-2025-00018
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Report Date
- December 12, 2025
- Manufacturer
- LOHMAN TECHNOLOGIES, LLC
- Product Code
- DXH
- UDI-DI
- 00860003939734
- PMA / PMN Number
- K052767
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS UNABLE TO COMPLETE THE BOOT-UP PROCESS DUE TO A FAILURE OF THE INTERNAL FLASH ON THE MAIN PROCESSOR.
Description of Event or Problem · 0
THE PATIENT REPORTS THAT THE DEVICE BLINKS A BLANK SCREEN DESPITE CHANGING BATTERIES. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2770496 | HOMECG+ | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | DXH | LOHMAN TECHNOLOGIES, LLC | V2.0 | 00860003939734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |