Brand Name | INTELLISPACE CC & ANESTHESIA |
Type of Device | INTELLISPACE CC & ANESTHESIA |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
wendy
chadbourne
|
3000 minuteman road |
andover, MA 01810
|
|
MDR Report Key | 5383569 |
MDR Text Key | 36633253 |
Report Number | 1218950-2016-00475 |
Device Sequence Number | 1 |
Product Code |
DXJ
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K100272 |
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,Followup |
Report Date |
01/13/2016 |
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 | 866072 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/13/2016 |
Initial Date FDA Received | 01/21/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/26/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Patient Outcome(s) |
Other;
|
|
|