Brand Name | AIRLIFE¿ |
Type of Device | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC. |
26125 n. riverwoods blvd |
mettawa IL 60045 |
|
MDR Report Key | 12467023 |
MDR Text Key | 271251746 |
Report Number | 12467023 |
Device Sequence Number | 1 |
Product Code |
BTM
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial |
Report Date |
09/03/2021,09/13/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/14/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Lot Number | 0004179972 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/03/2021 |
Date Report to Manufacturer | 09/14/2021 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Weight | 2 |
|
|