Brand Name | NOVA STAT PROFILE PRIME CCS COMP |
Type of Device | BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER |
Manufacturer (Section D) |
NOVA BIOMEDICAL CORP. |
200 prospect street |
waltham MA 02453 9141 |
|
Manufacturer (Section G) |
NOVA BIOMEDICAL CORP. |
200 prospect street |
|
waltham MA 02453 9141 |
|
Manufacturer Contact |
katrina
thorne gates
|
200 prospect street |
waltham, MA 02453-9141
|
7816473700
|
|
MDR Report Key | 13964206 |
MDR Text Key | 289102290 |
Report Number | 1219029-2022-00027 |
Device Sequence Number | 1 |
Product Code |
CHL
|
UDI-Device Identifier | 00385480528573 |
UDI-Public | 00385480528573 |
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K131703 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/31/2022 |
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 | PRIME CCS COMP |
Device Catalogue Number | 52857 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/04/2022 |
Initial Date FDA Received | 03/31/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |