FDA Adverse Event
Death
Summary report: N
TEMPUS PRO
MDR report key: 21637759
·
Received March 18, 2025
Report
- Report Number
- 3003832357-2025-000203
- Event Type
- Death
- Date Received
- March 18, 2025
- Date of Event
- February 14, 2025
- Report Date
- December 31, 2025
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441027
- PMA / PMN Number
- K201746
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
CORRECTION OF MFR REPORT NUMBER 3003832357-2025-000203. UPDATE TO EVENT AND DEATH DATE. ALSO, HEALTH IMPACT GRID.
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 DEVICE WAS DISPLAYING ASYSTOLE, YET THE CREW ON SCENE COULD FEEL A PALPABLE PULSE. THE PATIENT WENT INTO CARDIAC ARREST AND THE DEVICE DID PROVIDE SHOCKS TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5101 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1036-R | 05060472441027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |