Brand Name | ASSY PAT CIR W/O PEEP ADT SPU 10PK |
Type of Device | CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC |
cerrada vía de la producción |
no. 85 parque industrial |
mexicali baja california norte |
MX |
|
Manufacturer (Section G) |
VYAIRE MEDICAL, INC |
cerrada vía de la producción |
no.85 parque industrial |
mexicali baja california norte |
MX
|
|
Manufacturer Contact |
mindy
faber
|
26125 n. riverwoods blvd |
mettawa, IL 60045
|
|
MDR Report Key | 6745195 |
MDR Text Key | 81112221 |
Report Number | 8030673-2017-00357 |
Device Sequence Number | 1 |
Product Code |
CAI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
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,Followup |
Report Date |
11/22/2017 |
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 | 29657-001 |
Device Lot Number | 0001091757 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/26/2017 |
Initial Date FDA Received | 07/26/2017 |
Supplement Dates Manufacturer Received | 10/23/2017
|
Supplement Dates FDA Received | 11/23/2017
|
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
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|