Brand Name | HEARTSTART XL+ DEFIBRILLATOR/MONITOR |
Type of Device | DEFIBRILLATOR |
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 |
jacqueline
nishino
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 12047862 |
MDR Text Key | 257774937 |
Report Number | 3030677-2021-12387 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838023680 |
UDI-Public | 00884838023680 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K110825 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other Health Care Professional
|
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 |
Health Professional
|
Device Model Number | 861290 |
Device Catalogue Number | 861290 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 05/27/2021 |
Initial Date Manufacturer Received |
05/27/2021 |
Initial Date FDA Received | 06/23/2021 |
Supplement Dates Manufacturer Received | 05/27/2021
|
Supplement Dates FDA Received | 07/23/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/09/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|