Brand Name | 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) |
Type of Device | VENTILATOR, HIGH FREQUENCY |
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 |
peter
sparacio
|
26125 n. riverwoods blvd. |
mettawa, IL 60045
|
8333273284
|
|
MDR Report Key | 10872360 |
MDR Text Key | 217310041 |
Report Number | 2021710-2020-12889 |
Device Sequence Number | 1 |
Product Code |
LSZ
|
UDI-Device Identifier | 10846446003543 |
UDI-Public | (01)10846446003543(11)20200226 |
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 faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/26/2020 |
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 | 3100B |
Device Catalogue Number | 770155 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/26/2020 |
Initial Date FDA Received | 11/19/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/26/2020 |
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 |