Brand Name | PASSPORT 2 MONITOR |
Type of Device | PASSPORT 2 PATIENT MONITOR |
Manufacturer (Section D) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
buildings 9-13 baiwangxin |
high-tech industrial park |
baimang, xili town, nanshan, shenzen 51810 8 |
CH 518108 |
|
Manufacturer (Section G) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
buildings 9-13 baiwangxin |
high-tech industrial park |
baimang, xili town, nanshan, shenzen 51810 8 |
CH
518108
|
|
Manufacturer Contact |
serena
chen
|
1203 nanhuan avenue |
guangming district |
shenzhen, shenzhen 51810-6
|
CH
518106
|
|
MDR Report Key | 9885701 |
MDR Text Key | 185129536 |
Report Number | 3009156722-2020-00005 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K020550 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/28/2020 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0998-00-0900-5014A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/28/2020 |
Initial Date FDA Received | 03/26/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Age | 7 YR |
|
|