Brand Name | TRILOGY 100 |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS, INC |
1001 murry ridge rd |
murrysville, pa |
|
Manufacturer (Section G) |
RESPIRONICS, INC |
1001 murry ridge rd |
|
murrysville, pa |
|
Manufacturer Contact |
adam
price
|
312 alvin dr. |
new kensington, pa
|
3349303
|
|
MDR Report Key | 9756426 |
MDR Text Key | 181639366 |
Report Number | 2518422-2020-00498 |
Device Sequence Number | 1 |
Product Code |
CBK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083526 |
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 |
02/10/2020 |
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 | 1054260 |
Device Catalogue Number | 1054260 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/05/2020 |
Initial Date Manufacturer Received |
02/10/2020 |
Initial Date FDA Received | 02/26/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/15/2015 |
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 |
|
|