Brand Name | ASTRAL EXTERNAL BATTERY, ROW |
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 | 12194009 |
MDR Text Key | 264477460 |
Report Number | 3004604967-2021-00800 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00619498279180 |
UDI-Public | (01)00619498279180(10)1446246 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K152068 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/19/2021 |
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 | 27918 |
Device Catalogue Number | 27918 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/24/2021 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 06/20/2021 |
Initial Date Manufacturer Received |
06/20/2021 |
Initial Date FDA Received | 07/19/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/08/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |