Brand Name | AIRFLOW RESUCITATION BAG |
Manufacturer (Section D) |
VENTLAB CORP. |
grand rapids MI |
|
Manufacturer Contact |
rob
yamashita
|
2710 northridge dr., nw, ste. a |
grand rapids, MI 49544
|
6162598373
|
|
MDR Report Key | 4147217 |
MDR Text Key | 4771623 |
Report Number | 2246980-2014-00039 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K012842 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
09/30/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/30/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AF1140MB |
Device Lot Number | 105822, 108578, 108342 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/10/2013 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | RES68242 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|