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 |
|
MDR Report Key | 11101871 |
MDR Text Key | 228727659 |
Report Number | 2016493-2020-87144 |
Device Sequence Number | 1 |
Product Code |
CCK
|
UDI-Device Identifier | 10885403830013 |
UDI-Public | 10885403830013 |
Combination Product (y/n) | N |
PMA/PMN Number | K031741 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Type of Report
| Initial,Followup |
Report Date |
12/08/2020 |
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 | 8300 |
Device Catalogue Number | 8300 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/04/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/31/2020 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/03/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|