Brand Name | VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT |
Type of Device | ANESTHESIA BREATHING CIRCUIT |
Manufacturer (Section D) |
VYAIRE MEDICAL |
22745 savi ranch pkwy |
yorba linda CA 92887 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada vía de la producción |
# 85 parque industrial |
mexicali, mex 21397 |
MX
21397
|
|
Manufacturer Contact |
stanley
tan
|
22745 savi ranch pkwy |
yorba linda, CA 92887
|
7149193324
|
|
MDR Report Key | 8622131 |
MDR Text Key | 145511844 |
Report Number | 8030673-2019-00042 |
Device Sequence Number | 1 |
Product Code |
CAI
|
UDI-Device Identifier | 10885403244391 |
UDI-Public | (01)10885403244391(10)0004052958(11)180822 |
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 |
distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/17/2019 |
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 | B1714XXX |
Device Lot Number | 0004052958 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/17/2019 |
Initial Date FDA Received | 05/17/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |