Brand Name | A5 ANESTHESIA SYSTEM |
Type of Device | ANESTHESIA SYSTEM |
Manufacturer (Section D) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
buildings 9-13, baiwangxin |
high-tech industrial park |
baimang, xili town, nanshan, 51810 8 |
CH 518108 |
|
Manufacturer Contact |
serena
chen
|
buildings 9-13, baiwangxin |
high-tech industrial park |
baimang, xili town, nanshan, shenzhen 51810-8
|
CH
518108
|
|
MDR Report Key | 6644636 |
MDR Text Key | 77700973 |
Report Number | 3007222337-2017-00016 |
Device Sequence Number | 1 |
Product Code |
BSZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123211 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
06/13/2017,05/16/2017 |
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 |
No Information
|
Device Model Number | A5 |
Device Catalogue Number | 0631F-01000-06 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 05/16/2017 |
Date Report to Manufacturer | 06/13/2017 |
Initial Date Manufacturer Received |
05/16/2017 |
Initial Date FDA Received | 06/15/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Patient Outcome(s) |
Life Threatening;
|
|
|