Brand Name | HS1 HOME DEFIB, US ENGLISH, EXCHANGE |
Type of Device | AED |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
|
bothell WA 98021 |
|
Manufacturer Contact |
marie-therese
assaf
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 15870583 |
MDR Text Key | 304417847 |
Report Number | 3030677-2022-05365 |
Device Sequence Number | 1 |
Product Code |
NSA
|
UDI-Device Identifier | 00884838075849 |
UDI-Public | 00884838075849 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P160029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
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 |
Other
|
Device Model Number | M5068A |
Device Catalogue Number | 453564428311 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/04/2022 |
Initial Date Manufacturer Received |
11/23/2022 |
Initial Date FDA Received | 11/28/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|