Brand Name | PHILIPS RESPIRONICS |
Type of Device | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS CALIFORNIA, INC. |
2271 cosmos ct |
carlsbad CA 92011 |
|
MDR Report Key | 10454277 |
MDR Text Key | 204394924 |
Report Number | 10454277 |
Device Sequence Number | 1 |
Product Code |
MNT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
08/12/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | V60 |
Device Catalogue Number | 144164-M |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/12/2020 |
Event Location |
Other
|
Date Report to Manufacturer | 08/26/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/26/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 23725 DA |
|
|