Brand Name | CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD |
Type of Device | CONNECTOR, AIRWAY (EXTENSION) |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC |
26125 n riverwoods blvd |
mettawa IL 60045 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL, INC |
cerrada via de la produccion |
no. 85., parque industrial mex |
mexicali baja california norte |
MX
|
|
Manufacturer Contact |
mindy
faber
|
26125 n riverwoods blvd |
mettawa, IL 60045
|
|
MDR Report Key | 7063017 |
MDR Text Key | 93062067 |
Report Number | 8030673-2017-00388 |
Device Sequence Number | 1 |
Product Code |
BZA
|
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 |
health professional,user faci |
Reporter Occupation |
Respiratory Therapist
|
Type of Report
| Initial,Followup |
Report Date |
12/11/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/28/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 004081-A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/01/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|