Brand Name | HS1 (W B) HOME DEFIB, US ENGLISH, EXCHG |
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 |
shannon
decker
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 11396143 |
MDR Text Key | 234225070 |
Report Number | 3030677-2021-10040 |
Device Sequence Number | 1 |
Product Code |
NSA
|
UDI-Device Identifier | 00884838075849 |
UDI-Public | 00884838075849 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P160029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
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 | M5068A |
Device Catalogue Number | 453564596101 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 02/08/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/01/2021 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/09/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/01/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|