Brand Name | SERVO-I |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
MAQUET CRITICAL CARE AB |
roentgenvagen 2 |
solna |
|
Manufacturer (Section G) |
MAGNUS LINDQVIST |
maquet critical care ab |
röntgenvägen 2, se-171 54 |
solna |
SW
|
|
Manufacturer Contact |
|
maquet critical care ab |
röntgenvägen 2, se-171 54 |
solna
|
|
MDR Report Key | 8474642 |
MDR Text Key | 140900831 |
Report Number | 8010042-2019-00226 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
PMA/PMN Number | K123149 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
06/28/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/02/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 6487800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/28/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/25/2007 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|