Brand Name | FISHER PAYKEL HEALTHCARE |
Type of Device | HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER |
Manufacturer (Section D) |
FISHER PAYKEL HEALTHCARE LIMITED |
173 technology dr |
irvine CA 92618 |
|
MDR Report Key | 8435928 |
MDR Text Key | 139370833 |
Report Number | 8435928 |
Device Sequence Number | 1 |
Product Code |
BZE
|
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 |
02/12/2019,11/16/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/20/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | RT266 |
Device Catalogue Number | RT266 |
Device Lot Number | 2100524920 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/12/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/13/2019 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|