Brand Name | V60 VENTILATOR |
Type of Device | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,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 |
neisha
markham
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 7617585 |
MDR Text Key | 111945644 |
Report Number | 2031642-2018-01242 |
Device Sequence Number | 1 |
Product Code |
MNT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K082660 |
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,Followup |
Report Date |
05/22/2018 |
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 | V60 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/22/2018 |
Initial Date FDA Received | 06/19/2018 |
Supplement Dates Manufacturer Received | 05/22/2018 05/22/2018
|
Supplement Dates FDA Received | 08/09/2018 08/10/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/14/2015 |
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 |
|
|