Brand Name | BOXED PATIENT CIRCUIT ASSY, 3100A, 850L |
Type of Device | VENTILATOR, HIGH FREQUENCY |
Manufacturer (Section D) |
VYAIRE MEDICAL |
510 technology dr |
irvine IL 92618 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada via de la produccion |
no. 85, parque undustrial mex |
mexicali, 21397 |
MX
21397
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 13261981 |
MDR Text Key | 288196290 |
Report Number | 8030673-2022-00228 |
Device Sequence Number | 1 |
Product Code |
LSZ
|
UDI-Device Identifier | 50190752155259 |
UDI-Public | (01)50190752155259(10)0004155821 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P890057 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/15/2021 |
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 Model Number | BOXED PATIENT CIRCUIT ASSY, 3100A, 850L |
Device Catalogue Number | 29028-004 |
Device Lot Number | 0004155821 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/18/2021
|
Initial Date FDA Received | 01/14/2022 |
Supplement Dates Manufacturer Received | 11/15/2021
|
Supplement Dates FDA Received | 02/09/2022
|
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 |
Patient Outcome(s) |
Required Intervention;
|