FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 21180649
·
Received January 17, 2025
Report
- Report Number
- 3003832357-2025-000044
- Event Type
- Malfunction
- Date Received
- January 17, 2025
- Date of Event
- January 6, 2025
- Report Date
- April 30, 2025
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441027
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS IS A CORRECTION REPORT FOR MFR REPORT 3003832357-2025-000044 AS THE DATE RECEIVED BY MFG (RFB) WAS INCORRECT. UPDATED FROM 03/26/2025 TO 03/25/2025.
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT THE TEMPUS PRO, AFTER UPDATING THE TEMPUS SOFTWARE, IT SEEMS THAT THE ECG HAS SET HIGHER SENSITIVITY DURING RECORDING 12-LEAD ECG REPORTING MORE ARTIFACTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1059010 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1024-R | 05060472441027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |