FDA Adverse Event
Malfunction
Summary report: N
RHYTHMSTAR
MDR report key: 25263185
·
Received May 22, 2026
Report
- Report Number
- 3011265784-2026-00001
- Event Type
- Malfunction
- Date Received
- May 22, 2026
- Date of Event
- April 25, 2026
- Report Date
- May 22, 2026
- Manufacturer
- RHYTHMEDIX LLC
- Product Code
- QYX
- UDI-DI
- 00868282000220
- PMA / PMN Number
- K233584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE AND POWER SUPPLY ARE RETURNED FOR INSPECTION. THE DEVICE EMBEDS A SMALL SINGLE CELL LITHIUM-ION BATTERY (3.7V, 700MAH). THE BATTERY IS BEING RETURNED TO THE BATTERY MANUFACTURER FOR ANALYSIS. THE DEVICE WAS PLACED ON A CHARGING CRADLE LOCATED ON A KITCHEN COUNTER-TOP NEXT TO A PLUGGED-IN SLOW COOKER. A THIRD-PARTY USB POWER SUPPLY (NOT PART OF DEVICE) WAS USED TO CHARGE THE DEVICE AND SUPPLIED BY A MONITORING CENTER.
Description of Event or Problem · 0
A COMPLAINT WAS RECEIVED FROM A PATIENT REPORTING A MINOR DAMAGE TO A KITCHEN COUNTERTOP DUE TO DEVICE FIRE DURING DEVICE CHARGING. AT THIS POINT IN TIME, THE CAUSE OF THE FIRE REMAINS UNDER INVESTIGATION. THERE WERE NO INJURIES OR ADVERSE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543420 | RHYTHMSTAR | RHYTHMSTAR SYSTEM | QYX | RHYTHMEDIX LLC | RS-10003 | 00868282000220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |