Brand Name | 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) |
Type of Device | VENTILATOR, HIGH FREQUENCY |
Manufacturer (Section D) |
VYAIRE MEDICAL |
26125 north 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 | 18933520 |
MDR Text Key | 338360791 |
Report Number | 2021710-2024-18902 |
Device Sequence Number | 1 |
Product Code |
LSZ
|
UDI-Device Identifier | 10846446003079 |
UDI-Public | (01)10846446003079(11)20230519 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P890057 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/19/2024 |
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 Model Number | 3100A VENT,115V,60HZ,DOM |
Device Catalogue Number | 768901 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/22/2024
|
Initial Date FDA Received | 03/19/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/19/2023 |
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 |