Brand Name | TRILOGY 100 |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS, INC |
1001 murry ridge lane |
murrysville PA 15668 |
|
Manufacturer (Section G) |
RESPIRONICS, INC |
1001 murry ridge lane |
|
murrysville PA 15668 |
|
Manufacturer Contact |
adam
price
|
312 alvin drive |
new kensington, PA 15068
|
7243349303
|
|
MDR Report Key | 7411373 |
MDR Text Key | 104877908 |
Report Number | 2518422-2018-00866 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00606959015364 |
UDI-Public | 00606959015364 |
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 |
company representative |
Reporter Occupation |
Service and Testing Personnel
|
Type of Report
| Initial |
Report Date |
11/13/2017 |
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 | 11/09/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/13/2017 |
Initial Date FDA Received | 04/10/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/30/2013 |
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 |
|
|