Brand Name | MX40 2.4 GHZ SMART HOPPING |
Type of Device | MX40 2.4 GHZ SMART HOPPING |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
betty
harris
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 7105975 |
MDR Text Key | 94555746 |
Report Number | 1218950-2017-08378 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K113125 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
11/30/2017 |
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 | 865351 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/27/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/30/2017 |
Initial Date FDA Received | 12/11/2017 |
Supplement Dates Manufacturer Received | 11/30/2017 11/30/2017 11/30/2017
|
Supplement Dates FDA Received | 02/27/2018 02/28/2018 03/20/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/17/2012 |
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 |