Brand Name | HEARTSTART XL+ DEFIBRILLATOR/MONITOR |
Type of Device | ALS DEFIBRILLATOR MONITOR |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
wendy
chadbourne
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 6767937 |
MDR Text Key | 82010041 |
Report Number | 1218950-2017-05293 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838023680 |
UDI-Public | (01)00884838023680 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
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
|
Type of Report
| Initial |
Report Date |
07/20/2017 |
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 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/20/2017 |
Initial Date FDA Received | 08/04/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/28/2015 |
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 |
|
|