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 |
betty
harris
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 7606241 |
MDR Text Key | 111682494 |
Report Number | 1218950-2018-05022 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | 00884838082236 |
UDI-Public | (01)00884838082236( |
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 |
health professional,user faci |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
05/18/2018 |
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 | 865350 |
Device Catalogue Number | 865350 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/18/2018 |
Initial Date FDA Received | 06/15/2018 |
Supplement Dates Manufacturer Received | 05/18/2018
|
Supplement Dates FDA Received | 08/17/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2016 |
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 |