Brand Name | EDAN |
Type of Device | HOLTER SYSTEM |
Manufacturer (Section D) |
EDAN INSTRUMENTS, INC. |
15 jinhui rd,jinsha community |
kengzi sub-district, pingshan |
shenzhen, 51812 2 |
CH 518122 |
|
Manufacturer (Section G) |
EDAN INSTRUMENTS, INC. |
15 jinhui rd, jinsha community |
kengzi sub-district, pingshan |
shenzhen, 51812 2 |
CH
518122
|
|
Manufacturer Contact |
alice
yang
|
15 jinhui rd, jinsha community |
kengzi sub-district, pingshan |
shenzhen, guangdong 51812-2
|
CH
518122
|
|
MDR Report Key | 8635774 |
MDR Text Key | 146224325 |
Report Number | 3003971136-2019-00001 |
Device Sequence Number | 0 |
Product Code |
DQK
|
Reporter Country Code | IT |
PMA/PMN Number | K151787 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
05/01/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | HOLTER SYSTEM ANALYSIS SOFTWARE |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/01/2019 |
Initial Date FDA Received | 05/23/2019 |
Supplement Dates Manufacturer Received | 05/01/2019
|
Supplement Dates FDA Received | 05/24/2019
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 15 YR |
|
|