FDA Adverse Event
Injury
Summary report: N
TEMPUS PRO
MDR report key: 17460454
·
Received August 4, 2023
Report
- Report Number
- 3003832357-2023-00517
- Event Type
- Injury
- Date Received
- August 4, 2023
- Date of Event
- July 22, 2023
- Report Date
- June 10, 2024
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472441058
- PMA / PMN Number
- K201746
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATED TYPE OF COMPLAINT - SERIOUS INJURY FROM PRODUCT PROBLEM.
Additional Manufacturer Narrative · 0
UPDATED HEALTH IMPACT CODE , COMPONENT CODE AND CONCLUSION CODE.
Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT THE TEMPUS PRO DISPLAYED AN ERROR MESSAGE AS MPM APPLICATION ¿ CANNOT LOCATE MPM APPLICATION.EXE. PLEASE RE-APPLY WITH THE LATEST SOFTWARE UPDATE. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. FURTHER UPDATES WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 952410 | 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 | Other |