Brand Name | ASTRAL 100 - AMER |
Manufacturer (Section D) |
RESMED LTD |
1 elizabeth macarthur drive |
bella vista |
sydney, nsw 2153 |
AU 2153 |
|
Manufacturer (Section G) |
RESMED LTD |
1 elizabeth macarthur drive |
bella vista |
sydney, nsw 2153 |
AU
2153
|
|
Manufacturer Contact |
michelle
hughes
|
1 elizabeth macarthur drive |
bella vista |
sydney, nsw 2153
|
AU
2153
|
|
MDR Report Key | 11277006 |
MDR Text Key | 231121317 |
Report Number | 3004604967-2021-00234 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00619498270019 |
UDI-Public | (01)00619498270019(11)190516(10)1381853 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K152068 |
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 |
02/03/2021 |
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 |
Lay User/Patient
|
Device Model Number | 27001 |
Device Catalogue Number | 27001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/01/2020 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 01/08/2021 |
Initial Date Manufacturer Received |
01/08/2021 |
Initial Date FDA Received | 02/03/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |