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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE

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RESPIRONICS, INC TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054260
Device Problem Aborted Charge (2288)
Patient Problem No Patient Involvement (2645)
Event Date 12/20/2017
Event Type  Malfunction  
Event Description

A ventilator was returned to the manufacturer for service. The device was not in patient use. During the evaluation of the device at the manufacturer's service center, the battery charging limit was found to be set to less than 100%. The device was recalibrated to address the issue.

 
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Brand NameTRILOGY 100
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key7411381
MDR Text Key104890354
Report Number2518422-2018-00871
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation SERVICE AND TESTING PERSONNEL
Type of Report Initial
Report Date 12/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1054260
Device Catalogue Number1054260
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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