FDA Adverse Event
Death
Summary report: N
TRILOGY 100 VENTILATOR
MDR report key: 14257479
·
Received April 29, 2022
Report
- Report Number
- MW5109442
- Event Type
- Death
- Date Received
- April 29, 2022
- Date of Event
- February 2, 2019
- Report Date
- April 26, 2022
- Manufacturer
- PHILIPS / RESPIRONICS INC.
- Product Code
- CBK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
AUNT USED TRILOGY 100 VENTILATOR MACHINE FROM 2017 TO 2021. LAST 2 YEARS, AUNT COMPLAINED TRILOGY MACHINE WASN'T WORKING CORRECTLY AND COULDN'T BREATHE, SO WE HAD TRILOGY REPLACED 3X BEFORE HER DEATH. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1353624 | TRILOGY 100 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | PHILIPS / RESPIRONICS INC. | 100 | ||
| 1353625 | TRILOGY 100 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | PHILIPS / RESPIRONICS INC. | 100 | ||
| 1353626 | TRILOGY 100 VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | PHILIPS / RESPIRONICS INC. | 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Death | OXYGEN - 3 LITERS |