Brand Name | NEBULIZER HEATER 1/CS |
Type of Device | NEBULIZER (DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD |
45-46 shabu industrial zone |
qiaolong district, tangxia |
dong guan guangdong,523730 |
CH |
|
Manufacturer (Section G) |
VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD |
45-46 shabu industrial zone |
qiaolong district, tangxia |
dong guan guangdong,523730 |
CH
|
|
Manufacturer Contact |
kristin
graf
|
22745 savi ranch parkway |
yorba linda, CA 92887
|
|
MDR Report Key | 7452888 |
MDR Text Key | 106245735 |
Report Number | 2050001-2018-00097 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K780456 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
04/23/2018 |
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 | 2M8021 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/27/2018
|
Initial Date FDA Received | 04/23/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|