Brand Name | PANORAMA CENTRAL STATION WITH TELEMETRY |
Type of Device | CENTRAL MONITORING STATION |
Manufacturer (Section D) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
1203 nanhuan avenue |
guangming district |
shenzhen, shenzhen 51810 6 |
CH 518106 |
|
Manufacturer (Section G) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
1203 nanhuan avenue |
guangming district |
shenzhen, guandong 51810 6 |
CH
518106
|
|
Manufacturer Contact |
patrice
martinez
|
800 macarthur blvd |
mahwah, NJ 07430
|
2019958026
|
|
MDR Report Key | 11510063 |
MDR Text Key | 267517286 |
Report Number | 3009156722-2015-00261 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142601 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/16/2021 |
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 | 0998-00-0710-01 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/16/2021 |
Initial Date FDA Received | 03/17/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |