Brand Name | ALARIS ETCO2 |
Type of Device | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS |
Manufacturer (Section D) |
CAREFUSION SD |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
Manufacturer (Section G) |
CAREFUSION SD |
10020 pacific mesa blvd |
|
san diego CA 92121 4386 |
|
Manufacturer Contact |
shari lynn
groth
|
10020 pacific mesa blvd |
san diego, CA 92121-4386
|
8586172000
|
|
MDR Report Key | 11103199 |
MDR Text Key | 224861083 |
Report Number | 2016493-2020-87261 |
Device Sequence Number | 1 |
Product Code |
CCK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K133532 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/09/2020 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/31/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 8300 |
Device Catalogue Number | 8300 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/14/2020 |
Is the Reporter a Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/07/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|
|
|