FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 21036530
·
Received December 30, 2024
Report
- Report Number
- 3003832357-2024-000886
- Event Type
- Malfunction
- Date Received
- December 30, 2024
- Date of Event
- December 19, 2024
- Report Date
- June 6, 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
UPDATE TO DESCRIPTION ORIGINALLY PROVIDED ON MFR REPORT NUMBER 3003832357-2024-000886.
Additional Manufacturer Narrative · 0
HEALTH IMPACT CODE UPDATED PER NEW INFORMATION.
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE HAS A CONNECTION ERROR WHEN ATTEMPTING TO CONNECT TO A TEMPUS PRO.
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT THE TEMPUS PRO DEVICE EXPERIENCED A CONNECTION ERROR WHEN ATTEMPTING TO CONNECT TO TEMPUS LS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2419712 | 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 |