Brand Name | AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER |
Type of Device | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
Manufacturer (Section D) |
VYAIRE MEDICAL |
510 technology dr |
irvine IL 92618 |
|
Manufacturer (Section G) |
CHINAMED PRODUCT (CHINA) LTD., |
xin tang industrial park, |
jiao tang town gaoyao district |
guangdong, 44526 100 |
CH
44526100
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 15154021 |
MDR Text Key | 304812059 |
Report Number | 3013421741-2022-00017 |
Device Sequence Number | 1 |
Product Code |
BZD
|
UDI-Device Identifier | 10190752144446 |
UDI-Public | (01)10190752144446(10)CM21J06 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031745 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/06/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/02/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AIRLIFE¿ AUTOFILL HUMIDIFICATION CHAMBER |
Device Catalogue Number | AH290 |
Device Lot Number | CM21J06 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/02/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |