Brand Name | TEMPUS PRO |
Type of Device | 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 |
mark
o'dwyer
|
ascent 1, aerospace centre |
aerospace boulevard |
farnborough GU14 -6XW
|
UK
GU14 6XW
|
|
MDR Report Key | 19106310 |
MDR Text Key | 340905320 |
Report Number | 3003832357-2024-00320 |
Device Sequence Number | 1 |
Product Code |
MHX
|
UDI-Device Identifier | 05060472441027 |
UDI-Public | 05060472441027 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K201746 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/01/2024 |
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 Operator |
Health Professional
|
Device Model Number | 00-1024-R |
Device Catalogue Number | 989706000051 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/09/2024 |
Initial Date FDA Received | 04/15/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/01/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|