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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 Problems Failure to Recalibrate (1517); Aborted Charge (2288)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  Malfunction  
Event Description

A ventilator was returned to the manufacturer for service. There was no harm or injury reported. During the evaluation of the device at the manufacturer's service center, the device failed a step during testing. The device's sensor board was replaced to address the issue. Error codes related to the charging of the internal battery were observed. The device's charge limit was reset to 100% 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 drive
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge drive
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensignton, PA 15068
7243349303
MDR Report Key11273516
MDR Text Key230081312
Report Number2518422-2021-00231
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
Type of Report Initial
Report Date 02/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2021
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 Manufacturer01/22/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/19/2014
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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