FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 19771574
·
Received July 18, 2024
Report
- Report Number
- 3003832357-2024-00543
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- July 5, 2024
- Report Date
- August 27, 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
UPDATED EVENT DATE.
Additional Manufacturer Narrative · 0
UPDATED DATE RECEIVED BY MFG (RFB) FROM 08/05/2025 ORIGINALLY REPORTED ON MFR REPORT NUMBER 3003832357-2024-00543 TO 08/04/2025.
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT TEMPUS LS AND TEMPUS PRO HAD DIFFICULTIES CONNECTING. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1555434 | 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 |