Brand Name | S7-3T - 989605406771 |
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 | 10345272 |
MDR Text Key | 201323906 |
Report Number | 3019216-2020-00047 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K043535 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
07/02/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/30/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Model Number | 989605406772 |
Device Lot Number | B2HWWZ |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/08/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 07/02/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/28/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Treatment Data |
Date Received: 07/30/2020 Patient Sequence Number: 1 |
|
|