Brand Name | FR3 DEFIB, ECG UK ENGLISH (T) 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 |
shannon
decker
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 12455240 |
MDR Text Key | 270995051 |
Report Number | 3030677-2021-14227 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838049994 |
UDI-Public | 00884838049994 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | P160028 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
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 |
Other
|
Device Model Number | 861389 |
Device Catalogue Number | 453564405921 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 08/16/2021 |
Initial Date Manufacturer Received |
08/16/2021 |
Initial Date FDA Received | 09/10/2021 |
Supplement Dates Manufacturer Received | 11/01/2021
|
Supplement Dates FDA Received | 11/02/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2018 |
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 |
|
|