Brand Name | ASTRAL EXTERNAL BATTERY, AMERICAS |
Manufacturer (Section D) |
RESMED LTD |
1 elizabeth macarthur drive. |
bella vista |
sydney, nsw 2153 |
AU 2153 |
|
Manufacturer (Section G) |
RESMED CORP |
9001 spectrum center blvd |
|
san diego CA 92123 |
|
Manufacturer Contact |
ariana
beck
|
9001 spectrum center blvd |
san diego, CA 92123
|
|
MDR Report Key | 8511888 |
MDR Text Key | 141915902 |
Report Number | 3004604967-2019-00126 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00619498279197 |
UDI-Public | (01)00619498279197(11)180508(10)1305028 |
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 |
04/12/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/12/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 27919 |
Device Catalogue Number | 27919 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 03/20/2019 |
Device Age | 10 MO |
Date Manufacturer Received | 03/20/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |