FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 19894292
·
Received August 2, 2024
Report
- Report Number
- 3003832357-2024-00586
- Event Type
- Malfunction
- Date Received
- August 2, 2024
- Date of Event
- July 24, 2024
- Report Date
- October 15, 2024
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441058
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT HAS BEEN REPORTED THAT THE DEVICE ETCO2 PORT IS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1216994 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1026-R | 05060472441058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |