FDA Adverse Event
Malfunction
Summary report: N
TEMPUS PRO
MDR report key: 17414584
·
Received July 28, 2023
Report
- Report Number
- 3003832357-2023-00500
- Event Type
- Malfunction
- Date Received
- July 28, 2023
- Date of Event
- February 2, 2023
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- 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
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE TOUCH SCREEN DOES NOT WORK (REPORTED UNDER 2981038). BASED ON THE TESTING CONDUCTED IT WAS FOUND THE CHARGING PORT AND CO2 CONNECTORS ARE DAMAGED. DAMAGED CAPNOMETER HAS BEEN REPLACED. DEVICE FUNCTIONS ARE WORKING CORRECTLY. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2326734 | TEMPUS PRO | MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1024-R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |