Brand Name | ASTRAL EXTERNAL BATTERY, ROW |
Manufacturer (Section D) |
RESMED LTD |
1 elizabeth macarthur drive. |
bella vista |
sydney, nsw 2153 |
AU 2153 |
|
MDR Report Key | 10172265 |
MDR Text Key | 195732413 |
Report Number | 3007573469-2020-00679 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | AU |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/18/2020 |
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 | 27918 |
Device Catalogue Number | 27918 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/31/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/18/2020 |
Distributor Facility Aware Date | 05/21/2020 |
Device Age | 13 MO |
Date Report to Manufacturer | 06/18/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/18/2020 |
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 |
|
|