Brand Name | S8-3T MICRO TEE TRANSDUCER |
Type of Device | S8-3T MICRO TEE TRANSDUCER |
Manufacturer (Section D) |
PHILIPS ULTRASOUND, INC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer Contact |
tara
mackinnon
|
22100 bothell everett highway |
bothell, WA 98021
|
4254877000
|
|
MDR Report Key | 5158777 |
MDR Text Key | 28915974 |
Report Number | 3019216-2015-00055 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K030455 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/01/2015 |
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 Lot Number | B11XRG |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/01/2016 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/01/2015
|
Initial Date FDA Received | 10/19/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/02/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/31/2011 |
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 |
|
|