FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO, PRINTER
MDR report key: 23233625
·
Received October 7, 2025
Report
- Report Number
- 3003832357-2025-000721
- Event Type
- Malfunction
- Date Received
- October 7, 2025
- Date of Event
- August 5, 2025
- Report Date
- November 25, 2025
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472442925
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PREVIOUSLY REPORTED ON (B)(4) WITH MDR # 3003832357-2025-000720. DEVICE INVESTIGATION HAS TAKEN PLACE ON (B)(4) WITH MDR # 3003832357-2025-000720.
Description of Event or Problem · 0
THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER, A BENCH ENGINEER AND A TECHNICAL ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE SHOWS A ¿CELL PHONE FAULT¿ ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT ON THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1488397 | TEMPUS PRO, PRINTER | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1024-R | 05060472442925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |