FDA Adverse Event
Injury
Summary report: N
TEMPUS PRO, PRINTER
MDR report key: 23541722
·
Received November 13, 2025
Report
- Report Number
- 3003832357-2025-000846
- Event Type
- Injury
- Date Received
- November 13, 2025
- Date of Event
- November 7, 2025
- Report Date
- November 14, 2025
- Manufacturer
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Product Code
- MHX
- UDI-DI
- 05060472442925
- PMA / PMN Number
- K201746
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATED THE TYPE OF REPORTED PROBLEM TO SERIOUS INJURY.
Description of Event or Problem · 0
THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THE DEVICE SCREEN WILL NOT RETAIN CALIBRATION. SCREEN CALIBRATION IS OFF; AFTER RE-CALIBRATION, IT DOES NOT RETAIN THE NEW CALIBRATION. RENDERS THE UNIT INOPERATIVE BECAUSE USERS CANNOT SELECT COMMANDS ON THE SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2248766 | TEMPUS PRO, PRINTER | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | REMOTE DIAGNOSTIC TECHNOLOGIES LTD. | 00-1024-R | 05060472442925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |