Brand Name | ASTRAL 150 - 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 | 9735297 |
MDR Text Key | 188528678 |
Report Number | 3004604967-2020-00270 |
Device Sequence Number | 1 |
Product Code |
CBK
|
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
|
Source Type |
distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/20/2020 |
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 |
Lay User/Patient
|
Device Model Number | 27003 |
Device Catalogue Number | 27003 |
Device Lot Number | 1122206 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/30/2020 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 01/24/2020 |
Initial Date Manufacturer Received |
01/24/2020 |
Initial Date FDA Received | 02/20/2020 |
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 |
|
|