Brand Name | RESPIRONICS |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS CALIFORNIA, LLC |
2271 cosmos court |
carlsbad CA 92011 |
|
Manufacturer (Section G) |
RESPIRONICS CALIFORNIA, LLC |
2271 cosmos court |
|
carlsbad CA 92011 |
|
Manufacturer Contact |
melissa
abbott
|
2271 cosmos court |
carlsbad, CA 92011
|
7609187300
|
|
MDR Report Key | 11711098 |
MDR Text Key | 246997773 |
Report Number | 2031642-2021-03459 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102054 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
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 Model Number | V200 |
Device Catalogue Number | 1060264 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 03/23/2021 |
Initial Date Manufacturer Received |
03/23/2021 |
Initial Date FDA Received | 04/22/2021 |
Supplement Dates Manufacturer Received | 03/08/2022
|
Supplement Dates FDA Received | 03/18/2022
|
Date Device Manufactured | 11/05/2005 |
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 |
|
|