Brand Name | MX40 1.4 GHZ SMART HOPPING |
Type of Device | MX40 1.4 GHZ SMART HOPPING |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
robert
corning
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 10449453 |
MDR Text Key | 205307638 |
Report Number | 1218950-2020-04922 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113125 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/24/2020 |
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 |
Other
|
Device Model Number | 865350 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/28/2020 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/20/2020 |
Initial Date FDA Received | 08/25/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/08/2016 |
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 |