Brand Name | VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT |
Type of Device | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
Manufacturer (Section D) |
VYAIRE MEDICAL. |
26125 n. riverwoods blvd. |
mettawa, il |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada via de la produccion85 |
parque undustrial mexicali iii |
mexicali, 21397 |
MX
21397
|
|
Manufacturer Contact |
mindy
faber
|
26125 n. riverwoods blvd. |
mettawa, il
|
7570116
|
|
MDR Report Key | 9771963 |
MDR Text Key | 206393395 |
Report Number | 8030673-2020-00083 |
Device Sequence Number | 1 |
Product Code |
OFP
|
UDI-Device Identifier | 10190752123014 |
UDI-Public | (01)10190752123014(10)2022-04-30 |
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 |
user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/28/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT |
Device Catalogue Number | AMY520X4F |
Device Lot Number | 2022-04-30 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/14/2020 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/30/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |