Brand Name | V200 VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS CALIFORNIA, INC |
2271 cosmos court |
carlsbad CA 92011 |
|
Manufacturer (Section G) |
RICA |
2271 cosmos court |
|
carlsbad CA 92011 |
|
Manufacturer Contact |
yobana
sanchez
|
2271 cosmos court |
carlsbad, CA 92011
|
9093746996
|
|
MDR Report Key | 11554572 |
MDR Text Key | 243117606 |
Report Number | 2031642-2021-00979 |
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 |
Report Date |
08/05/2022 |
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 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/12/2021 |
Initial Date FDA Received | 03/23/2021 |
Supplement Dates Manufacturer Received | 08/03/2022
|
Supplement Dates FDA Received | 08/05/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/21/2013 |
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 |
Treatment | UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER |
|
|