Brand Name | CIRCUIT, INFANT DUAL LIMB,DHEAT, HI-FLOW |
Type of Device | HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER |
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 |
mexicali baja california norte |
MX
|
|
Manufacturer Contact |
mindy
faber
|
26125 n riverwoods blvd |
mettawa, IL 60045
|
|
MDR Report Key | 7183326 |
MDR Text Key | 97004249 |
Report Number | 8030673-2018-00408 |
Device Sequence Number | 1 |
Product Code |
BZE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151303 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/22/2018 |
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 | AH165 |
Device Lot Number | 0001097570 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/08/2017 |
Initial Date FDA Received | 01/11/2018 |
Supplement Dates Manufacturer Received | 02/02/2018
|
Supplement Dates FDA Received | 02/22/2018
|
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|