Brand Name | RESPIRONICS |
Type of Device | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
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 | 13830991 |
MDR Text Key | 287699336 |
Report Number | 2031642-2022-00712 |
Device Sequence Number | 1 |
Product Code |
MNS
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K053168 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup,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 Operator |
Health Professional
|
Device Model Number | BIPAP FOCUS SYSTEM, INT'L, RENTAL |
Device Catalogue Number | R1033869 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/09/2022
|
Initial Date FDA Received | 03/20/2022 |
Supplement Dates Manufacturer Received | 04/05/2022 04/10/2022 04/28/2022 05/05/2022
|
Supplement Dates FDA Received | 04/25/2022 04/27/2022 04/29/2022 05/27/2022
|
Date Device Manufactured | 06/20/2008 |
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 |