Brand Name | X7-2T TRANSDUCER (MTEE) |
Type of Device | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
Manufacturer (Section D) |
PHILIPS ULTRASOUND, INC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
paul
corrigan
|
22100 bothell everett highway |
bothell, WA 98021
|
4254877000
|
|
MDR Report Key | 7313431 |
MDR Text Key | 101657555 |
Report Number | 3019216-2018-00014 |
Device Sequence Number | 1 |
Product Code |
ITX
|
UDI-Device Identifier | 00884838061668 |
UDI-Public | (01)00884838061668 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
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 |
02/08/2018 |
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 | 989605414122 |
Device Lot Number | B25D6M |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/19/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/08/2018 |
Initial Date FDA Received | 03/05/2018 |
Supplement Dates Manufacturer Received | 02/08/2018
|
Supplement Dates FDA Received | 05/24/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/28/2017 |
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 |
|
|