Brand Name | ANES CIRCUIT, ADULT, 72 IN CORR |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC |
26125 n riverwoods blvd |
mettawa IL 60045 |
|
MDR Report Key | 7156613 |
MDR Text Key | 96134090 |
Report Number | 8030673-2018-00396 |
Device Sequence Number | 1 |
Product Code |
CAI
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Type of Report
| Initial,Followup |
Report Date |
02/20/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | AFNXXXXX |
Device Lot Number | 0001161276 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/08/2017
|
Initial Date FDA Received | 01/02/2018 |
Supplement Dates Manufacturer Received | 01/30/2018
|
Supplement Dates FDA Received | 02/20/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|