Brand Name | HEARTSTART MRX -EMS DEFIBRILLATOR |
Type of Device | DEFIBRILLATOR |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
bothell WA 98021 |
|
MDR Report Key | 11424111 |
MDR Text Key | 238647158 |
Report Number | 3030677-2021-10106 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838006652 |
UDI-Public | 00884838006652 |
Combination Product (y/n) | N |
PMA/PMN Number | K031187 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
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 | M3536A |
Device Catalogue Number | M3536A |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 02/10/2021 |
Initial Date Manufacturer Received |
02/10/2021 |
Initial Date FDA Received | 03/05/2021 |
Supplement Dates Manufacturer Received | 02/10/2021
|
Supplement Dates FDA Received | 05/13/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|