Brand Name | FR3, REFURB ECG AED - JAPANESE |
Type of Device | AED |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
22100 bothell everett hwy |
bothell WA 98021 |
|
Manufacturer Contact |
shannon
decker
|
22100 bothell-everett hwy |
bldg a |
bothell, WA 98021
|
|
MDR Report Key | 9353488 |
MDR Text Key | 174702086 |
Report Number | 3030677-2019-02320 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 0884838049994 |
UDI-Public | (01)0884838049994 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K111693 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/12/2019 |
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 |
Health Professional
|
Device Model Number | 861389 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/12/2019 |
Initial Date FDA Received | 11/21/2019 |
Supplement Dates Manufacturer Received | 11/12/2019 11/12/2019
|
Supplement Dates FDA Received | 01/27/2020 04/20/2020
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/01/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|