Brand Name | TRILOGY O2 |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS, INC |
1001 murry ridge lane |
murrysville PA 15668 |
|
MDR Report Key | 11665005 |
MDR Text Key | 245372708 |
Report Number | 2518422-2021-01072 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00606959025394 |
UDI-Public | 00606959025394 |
Combination Product (y/n) | N |
PMA/PMN Number | K093905 |
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 |
04/18/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1040004 |
Device Catalogue Number | 1040004 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/30/2021 |
Initial Date Manufacturer Received |
03/30/2021 |
Initial Date FDA Received | 04/14/2021 |
Supplement Dates Manufacturer Received | 04/15/2021
|
Supplement Dates FDA Received | 04/19/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|