Brand Name | WATER STERILE F/INHALATION 2000ML 6/CS |
Type of Device | HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC |
26125 north riverwoods blvd. |
mettawa IL 60045 |
|
Manufacturer (Section G) |
PISA FARMACEUTICA |
calle 7 #1308 |
col. zona industrial |
guadalajara ja 44940 |
MX
44940
|
|
Manufacturer Contact |
kristin
graf
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
|
MDR Report Key | 7038176 |
MDR Text Key | 92276408 |
Report Number | 2050001-2017-00086 |
Device Sequence Number | 1 |
Product Code |
BTT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090915 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/16/2017 |
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 | 2D0737 |
Device Lot Number | Q1707744 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/17/2017
|
Initial Date FDA Received | 11/16/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|