Brand Name | BLOOD GAS MONITOR |
Manufacturer (Section D) |
MAQUET CARDIOPULMONARY AG |
rastatt |
GM |
|
Manufacturer Contact |
michael
campbell
|
kehler strabe 31 |
restatt 76437
|
GM
76437
|
2229321132
|
|
MDR Report Key | 4768716 |
MDR Text Key | 5787714 |
Report Number | 8010762-2015-00441 |
Device Sequence Number | 1 |
Product Code |
DRY
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K090147 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/16/2015 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | BMU 40 |
Device Catalogue Number | 70104.08952 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/16/2015
|
Initial Date FDA Received | 05/11/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2009 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|