TRILOGY 202 1040007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for TRILOGY 202 1040007 manufactured by Respironics, Inc.

Event Text Entries

[185710693] A ventilator was returned to the manufacturer for routine preventive maintenance. There was no allegation of device malfunction. The device was not in patient use. During the evaluation of the device at the manufacturer's service center, an issue related to the active exhalation control module was observed. The device's active exhalation control module was replaced to address the issue. The device had evidence of physical damage.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518422-2020-00804
MDR Report Key9902725
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-17
Date of Event2020-03-17
Date Mfgr Received2020-03-17
Device Manufacturer Date2017-10-12
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ADAM PRICE
Manufacturer Street312 ALVIN DR.
Manufacturer CityNEW KENSINGTON, PA
Manufacturer CountryUS
Manufacturer Phone3349303
Manufacturer G1RESPIRONICS, INC
Manufacturer Street1001 MURRY RIDGE RD
Manufacturer CityMURRYSVILLE, PA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRILOGY 202
Generic NameVENTILATOR, CONTINUOUS, FACILITY USE
Product CodeCBK
Date Received2020-03-31
Returned To Mfg2020-03-02
Model Number1040007
Catalog Number1040007
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRESPIRONICS, INC
Manufacturer Address1001 MURRY RIDGE RD MURRYSVILLE, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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