TRILOGY 100 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 2020-03-31 for TRILOGY 100 1054260 manufactured by Respironics, Inc..

Event Text Entries

[185709981] A ventilator was returned to the manufacturer for routine preventative maintenance. There was no allegation of device malfunction. There was no harm or injury reported. During the evaluation of the device at the manufacturer's service center, a "service required" code was found in the ventilator's downloaded error log. The device's power management board was replaced to address the issue. During the evaluation of the device at the manufacturer's service center, a "ventilator inoperative" code was found in the ventilator's downloaded error log. The device's system board was replaced to address the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2518422-2020-00769
MDR Report Key9903048
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2013-05-01
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 100
Generic NameVENTILATOR, CONTINUOUS, FACILITY USE
Product CodeCBK
Date Received2020-03-31
Returned To Mfg2020-03-11
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 RD MURRYSVILLE, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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