FDA Adverse Event
Death
Summary report: N
TEMPUS PRO
MDR report key: 19465934
·
Received June 5, 2024
Report
- Report Number
- 3003832357-2024-00435
- Event Type
- Death
- Date Received
- June 5, 2024
- Date of Event
- May 31, 2024
- Report Date
- August 28, 2024
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441027
- PMA / PMN Number
- K201746
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT USER HAD AN ISSUE THAT WHAT THEY SAW ON THE SCREEN OF THE MONITOR WAS NOT WHAT IS SHOWING ON CORSIUM. THE CLINICIAN IS SAYING THAT THE PATIENT SHOWED ASYSTOLE ON THE MONITOR, HOWEVER THERE APPEARS TO BE COMPLEXES ON THE ECG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 854800 | 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 |