Brand Name | SERVO-I |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
MAQUET CRITICAL CARE AB |
roentgenvagen 2 |
solna |
|
Manufacturer (Section G) |
MAQUET CRITICAL CARE AB |
roentgenvagen 2 |
|
solna |
|
Manufacturer Contact |
sara
soderholm roman
|
roentgenvagen 2 |
solna
|
|
MDR Report Key | 11503497 |
MDR Text Key | 240404011 |
Report Number | 8010042-2021-00573 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123149 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/17/2021 |
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 | SERVO-I |
Device Catalogue Number | 6487800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/04/2021 |
Initial Date FDA Received | 03/17/2021 |
Supplement Dates Manufacturer Received | 11/08/2021
|
Supplement Dates FDA Received | 11/08/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/01/2007 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|