Brand Name | OMNIDIAGNOST ELEVA |
Manufacturer (Section D) |
PHILIPS HEALTHCARE |
veenpluis 4-6 |
best 5680 DA |
NL 5680 DA |
|
Manufacturer Contact |
deborah
thurston
|
3000 minuteman rd. |
andover, MA 01810
|
9786592010
|
|
MDR Report Key | 4317058 |
MDR Text Key | 5135462 |
Report Number | 3003768277-2014-00131 |
Device Sequence Number | 1 |
Product Code |
IZI
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K032046 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/06/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 708027 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/06/2014 |
Initial Date FDA Received | 12/04/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 99 YR |
|
|