Brand Name | AIRFLOW |
Type of Device | RESUS BAG |
Manufacturer (Section D) |
VENTLAB LLC. |
2710 northridgedr. suite a |
grand rapids MI 49544 |
|
Manufacturer (Section G) |
VENTLAB LLC. |
2710 northridgedr. suite a |
|
grand rapids MI 49544 |
|
Manufacturer Contact |
carrie
fortuna
|
2710 northridge dr. suite a |
grand rapids, MI 49544
|
6162598350
|
|
MDR Report Key | 5771696 |
MDR Text Key | 49575214 |
Report Number | 2246980-2016-00016 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
PMA/PMN Number | K012842 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 07/06/2016 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|