Brand Name | FR3 DEFIB, ECG, JAPANESE, 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 |
dana
tackett
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 13114513 |
MDR Text Key | 282960977 |
Report Number | 3030677-2021-16708 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838049994 |
UDI-Public | 00884838049994 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P160028 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,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 | 453564155061 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/14/2021 |
Initial Date FDA Received | 12/29/2021 |
Supplement Dates Manufacturer Received | 01/01/2022 01/31/2022
|
Supplement Dates FDA Received | 01/03/2022 01/31/2022
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/01/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|