Brand Name | ALARIS SYSTEM |
Type of Device | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
Manufacturer (Section D) |
CAREFUSION SD |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
Manufacturer Contact |
brett
wilko
|
10020 pacific mesa blvd |
san diego, CA 92121-4386
|
8586172000
|
|
MDR Report Key | 15646574 |
MDR Text Key | 306602858 |
Report Number | 2016493-2022-212967 |
Device Sequence Number | 1 |
Product Code |
CCK
|
UDI-Device Identifier | 10885403830013 |
UDI-Public | (01)10885403830013 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031741 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/10/2022 |
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 |
Other
|
Device Model Number | 8300 |
Device Catalogue Number | 8300 ALARIS ETCO2 MODULE |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/05/2022 |
Initial Date FDA Received | 10/21/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/21/2006 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|