Brand Name | TRILOGY EVO |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS, INC. |
1001 murry ridge drive |
murrysville PA 15668 |
|
Manufacturer (Section G) |
RESPIRONICS, INC. |
1001 murry ridge drive |
|
murrysville PA 15668 |
|
Manufacturer Contact |
adam
price
|
312 alvin drive |
new kensignton, PA 15068
|
7243349303
|
|
MDR Report Key | 11403887 |
MDR Text Key | 234408377 |
Report Number | 2518422-2021-00563 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00606959051942 |
UDI-Public | 00606959051942 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K181166 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/03/2021 |
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 | DS2110X11B |
Device Catalogue Number | DS2110X11B |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/23/2021 |
Initial Date Manufacturer Received |
02/05/2021 |
Initial Date FDA Received | 03/03/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/23/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|