Brand Name | SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) |
Type of Device | RESUSCITATION DEVICES |
Manufacturer (Section D) |
VYAIRE MEDICAL |
26125 n. riverwoods blvd. |
mettawa IL 60045 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada v?a de la producci?n |
no. 85, parque undustrial mex |
mexicali, 21397 |
MX
21397
|
|
Manufacturer Contact |
peter
sparacio
|
26125 n. riverwoods blvd. |
mettawa, IL 60045
|
8333273284
|
|
MDR Report Key | 11807424 |
MDR Text Key | 250025693 |
Report Number | 8030673-2021-00169 |
Device Sequence Number | 1 |
Product Code |
OEV
|
UDI-Device Identifier | 10190752145443 |
UDI-Public | (01)10190752145443(10)0004178443 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K020281 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/14/2021 |
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 |
Health Professional
|
Device Model Number | SUPERNOVA NASAL PAP VENTILATION SYSTEM (MEDIUM) |
Device Catalogue Number | SSM-20 |
Device Lot Number | 0004178443 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/15/2021 |
Initial Date FDA Received | 05/11/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |