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) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
wendy
chadbourne
|
2271 cosmos court |
carlsbad, CA 92011
|
9093746996
|
|
MDR Report Key | 6041371 |
MDR Text Key | 57872427 |
Report Number | 2031642-2016-02808 |
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 |
09/26/2016 |
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 | 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 |
09/26/2016 |
Initial Date FDA Received | 10/19/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/08/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/21/2009 |
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 |
|
|