FDA Adverse Event
Death
Summary report: N
TEMPUS PRO
MDR report key: 18826324
·
Received March 4, 2024
Report
- Report Number
- 3003832357-2024-00198
- Event Type
- Death
- Date Received
- March 4, 2024
- Date of Event
- February 17, 2024
- 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
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THE TEMPUS PRO - REF CASE (B)(4). NO ECG READING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178151 | 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 | Death |