| Brand Name | Tempus Pro, Printer, IBP |
| Common Device Name | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Manufacturer (Section D) |
| Remote Diagnostic Technologies Ltd. |
| ascent 1, aerospace centre |
| aerospace boulevard |
| farnborough GU14 6XW |
| UK GU14 6XW |
|
| Manufacturer (Section G) |
| Remote Diagnostic Technologies Ltd. |
| ascent 1, aerospace centre |
| aerospace boulevard |
| farnborough GU14 6XW |
|
UK
GU14 6XW
|
|
| Manufacturer Contact |
|
sharunyan
thavarajan
|
| ascent 1, aerospace centre |
| aerospace boulevard |
| farnborough GU14 -6XW
|
|
UK
GU14 6XW
|
|
| MDR Report Key | 50266750 |
| Report Number | 3003832357-2026-100471 |
| Device Sequence Number | 15805914 |
| Product Code |
MHX
|
| UDI-Device Identifier | 05060472442932 |
| UDI-Public | (01)05060472442932 |
| Combination Product (Y/N) | N |
| Initial Reporter State | IL |
| Initial Reporter Country | US |
| PMA/510(K) Number | K201746 |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
User Facility |
| Type of Report
| Initial |
| Report Date (Section B) |
08/15/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Device Model Number | 00-1026-R |
| Device Catalogue Number | 867423 |
| Was Device Available for Evaluation? |
Yes
|
| Is the Reporter a Health Professional? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 07/20/2026 |
| Initial Report FDA Received Date | 08/16/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Is the Device Labeled for Single Use? (Y/N) |
No
|
| Patient Sequence Number | 1 |
| Outcome Attributed to Adverse Event |
Other;
|
| Patient Sex | Unknown |
|
|