FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO, BT HEADSET DOCK
MDR report key: 23137160
·
Received September 24, 2025
Report
- Report Number
- 3003832357-2025-000694
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- September 19, 2025
- Report Date
- March 4, 2026
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472442918
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATED REPORTER COUNTRY TO FRANCE.
Description of Event or Problem · 0
THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE POWER CONNECTOR IS BROKEN. THERE WERE NO REPORTS OF PATIENT USE NOR IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515287 | TEMPUS PRO, BT HEADSET DOCK | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1007-R | 05060472442918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |