TRILOGY100 1054260

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 2020-03-30 for TRILOGY100 1054260 manufactured by Respironics Inc.

Event Text Entries

[185542682] A ventilator was returned to the manufacturer for routine preventative 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, the device failed a step during testing. The device's active exhalation control module was replaced to address the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518422-2020-00808
MDR Report Key9897906
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-17
Date of Event2020-03-17
Date Mfgr Received2020-03-17
Device Manufacturer Date2013-07-12
Date Added to Maude2020-03-30
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 DRIVE
Manufacturer CityNEW KENSINGTON, PA
Manufacturer CountryUS
Manufacturer Phone3349303
Manufacturer G1RESPIRONICS INC
Manufacturer Street1001 MURRY RIDGE LANE
Manufacturer CityMURRYSVILLE, PA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRILOGY100
Generic NameVENTILATOR, CONTINUOUS, FACILITY USE
Product CodeCBK
Date Received2020-03-30
Returned To Mfg2020-03-12
Model Number1054260
Catalog Number1054260
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRESPIRONICS INC
Manufacturer Address1001 MURRY RIDGE LANE MURRYSVILLE, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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