Brand Name | M2M ASSY,LTV1150,WITH ACCESS.ENGLISH |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
VYAIRE MEDICAL |
26125 n. riverwoods blvd. |
mettawa IL 60045 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL INC. |
1100 bird center drive |
|
palm springs CA 92262 |
|
Manufacturer Contact |
sandra
valencia
|
510 technology drive |
irvine, CA 92618
|
2402760001
|
|
MDR Report Key | 19209903 |
MDR Text Key | 341382858 |
Report Number | 2021710-2024-19068 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00845873002726 |
UDI-Public | (01)00845873002726 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101643 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/29/2024 |
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 Catalogue Number | 18984-001 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/18/2024
|
Initial Date FDA Received | 04/29/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/25/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |