Brand Name | AZURION |
Type of Device | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
veenpluis 6 |
best 5684 PC |
NL 5684 PC |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
veenpluis 6 |
|
best 5684 PC |
NL
5684 PC
|
|
Manufacturer Contact |
derrick
massuri
|
3000 minuteman rd |
andover, MA 01810
|
6172455900
|
|
MDR Report Key | 18889088 |
MDR Text Key | 337485549 |
Report Number | 3003768277-2024-01752 |
Device Sequence Number | 1 |
Product Code |
OWB
|
UDI-Device Identifier | 00884838099258 |
UDI-Public | 00884838099258 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K200917 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/12/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | AZURION 7 M20 |
Device Catalogue Number | 722224 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 03/06/2024 |
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 |