FDA Adverse Event
Malfunction
Summary report: N
TRILOGY 100
MDR report key: 17464013
·
Received August 4, 2023
Report
- Report Number
- 2518422-2023-18300
- Event Type
- Malfunction
- Date Received
- August 4, 2023
- Date of Event
- September 10, 2021
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Removal / Correction Number
- RES 88071
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIE D SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP , BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT HAS ALLEGED THAT HEALTH ISSUES DUE TO USING THE DEVICE ALSO HAD ISSUES WITH THE DEVICE ALARMING FOR RESPIRATORY ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 891693 | TRILOGY 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS, INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |