Brand Name | EFFICIA CM120 |
Type of Device | EFFICIA CM120 |
Manufacturer (Section D) |
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC |
no.2 keji north 3rd road |
nanshan district |
shenzhen |
CH |
|
Manufacturer (Section G) |
PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC |
no.2 keji north 3rd road |
nanshan district |
shenzhen |
CH
|
|
Manufacturer Contact |
tara
mackinnon
|
222 jacobs st |
cambridge, MA 02141
|
6172455900
|
|
MDR Report Key | 13343087 |
MDR Text Key | 284370146 |
Report Number | 1218950-2022-00066 |
Device Sequence Number | 1 |
Product Code |
MHX
|
Combination Product (y/n) | N |
Reporter Country Code | TU |
PMA/PMN Number | K151812 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
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 Model Number | 863302 |
Device Catalogue Number | 863302 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/17/2022
|
Initial Date FDA Received | 01/25/2022 |
Supplement Dates Manufacturer Received | 07/27/2022
|
Supplement Dates FDA Received | 08/25/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/06/2020 |
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 |
|
|