FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 19654293
·
Received July 2, 2024
Report
- Report Number
- 3003832357-2024-00511
- Event Type
- Malfunction
- Date Received
- July 2, 2024
- Date of Event
- April 5, 2024
- Report Date
- July 2, 2024
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441027
- PMA / PMN Number
- K201746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO PHILIPS THAT THE DEVICE CHARGING PORT WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785898 | 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 | Other |