FDA Adverse Event
Malfunction
Summary report: N
HOMECG+
MDR report key: 23791345
·
Received December 12, 2025
Report
- Report Number
- 3012267350-2025-00019
- 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 START A READING DUE TO THE SPRING CONTACTS UNDER THE ELECTRODES NOT MAKING CONTACT.
Description of Event or Problem · 0
THE PATIENT REPORTS THAT THE DEVICE SHUTS OFF AFTER BEING TURNED ON AND DOES NOT COMPLETE THE FULL COUNTDOWN. THE PATIENT HAS REPLACED THE BATTERIES BUT THE ISSUE PERSISTS. THE PATIENT HAD NO ADVERSE EVENT OR REACTION RESULTING FROM THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2758980 | HOMECG+ | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE | DXH | LOHMAN TECHNOLOGIES, LLC | V2.0 | 00860003939734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |