Brand Name | TRILOGY EVO |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS, INC |
1001 murry ridge rd |
murrysville, pa |
|
MDR Report Key | 10345103 |
MDR Text Key | 201033125 |
Report Number | 2518422-2020-01803 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
PMA/PMN Number | K181166 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Type of Report
| Initial,Followup |
Report Date |
03/12/2021 |
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 |
Health Professional
|
Device Model Number | IN2100X15B |
Device Catalogue Number | IN2100X15B |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/19/2020 |
Initial Date Manufacturer Received |
07/29/2020 |
Initial Date FDA Received | 07/30/2020 |
Supplement Dates Manufacturer Received | 02/18/2021
|
Supplement Dates FDA Received | 03/12/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Age | 70 YR |
|
|