Brand Name | S-CATH ESOPHAGEAL TEMPERATURE PROBE |
Type of Device | ESOPHAGEAL TEMPERATURE PROBE |
Manufacturer (Section D) |
CIRCA SCIENTIFIC, INC. |
14 inverness drive east |
suite h-136 |
englewood CO 80112 |
|
Manufacturer (Section G) |
CIRCA SCIENTIFIC, INC. |
14 inverness drive east |
suite h-136 |
englewood CO 80112 |
|
Manufacturer Contact |
fred
piazza
|
14 inverness drive east |
suite h-136 |
englewood, CO 80112
|
3039518767
|
|
MDR Report Key | 17627653 |
MDR Text Key | 322019801 |
Report Number | 3009437315-2023-00003 |
Device Sequence Number | 1 |
Product Code |
FLL
|
UDI-Device Identifier | 10860237000214 |
UDI-Public | 10860237000214 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112376 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/25/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | CS-2001 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/28/2023
|
Initial Date FDA Received | 08/25/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|