Brand Name | ASTRAL 150 - AMER |
Manufacturer (Section D) |
RESMED LTD |
1 elizabeth macarthur drive |
bella vista |
sydney, nsw 2153 |
AS 2153 |
|
Manufacturer (Section G) |
RESMED LTD |
1 elizabeth macarthur drive |
bella vista |
sydney, nsw 2153 |
AS
2153
|
|
Manufacturer Contact |
michelle
hughes
|
1 elizabeth macarthur drive |
bella vista |
sydney, nsw 2153
|
AS
2153
|
|
MDR Report Key | 14465583 |
MDR Text Key | 298050881 |
Report Number | 3004604967-2022-00359 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00619498270033 |
UDI-Public | (01)00619498270033(11)200804(10)1472577 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K172875 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/21/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 27003 |
Device Catalogue Number | 27003 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/01/2022 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 04/25/2022 |
Date Manufacturer Received | 04/25/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/05/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |