Brand Name | VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
Manufacturer (Section D) |
VYAIRE MEDICAL |
510 technology dr |
irvine IL 92618 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada via de la produccion |
no. 85, parque undustrial mex |
mexicali, 21397 |
MX
21397
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 14988154 |
MDR Text Key | 304373714 |
Report Number | 8030673-2022-00257 |
Device Sequence Number | 1 |
Product Code |
CAI
|
UDI-Device Identifier | 10190752119871 |
UDI-Public | (01)10190752119871 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/22/2022 |
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 | VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT |
Device Catalogue Number | A4U12214 |
Device Lot Number | NOT PROVIDED |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/22/2022 |
Initial Date FDA Received | 07/12/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |