Brand Name | HS1+ (W G) DEFIB, JAPANESE, 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 | 12724219 |
MDR Text Key | 279298630 |
Report Number | 3030677-2021-15313 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838075849 |
UDI-Public | 00884838075849 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P160029 |
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 |
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 | M5066A |
Device Catalogue Number | 453564508241 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/27/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/25/2021 |
Initial Date FDA Received | 10/29/2021 |
Supplement Dates Manufacturer Received | 02/05/2022
|
Supplement Dates FDA Received | 02/08/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/01/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|