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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 Premature Discharge of Battery (1057)
Patient Problem No Patient Involvement (2645)
Event Date 01/05/2017
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator failed to hold its internal battery charge. The device was not in patient use. The ventilator was returned to the manufacturer for evaluation and error codes related to the charging of the internal battery was observed. The device's internal battery and power management board were replaced to address the issues.
 
Manufacturer Narrative
The manufacturer previously reported an issue with the internal battery and power management board. The internal battery and power management board were returned to the manufacturer's quality assurance laboratory for further investigation. During the investigation the root cause of the internal battery not charging was found to be due to a. 5vdc cell imbalance. The power management board was evaluated by the manufacturer's quality assurance laboratory and was found to operate to design specifications.
 
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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
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key6275743
MDR Text Key65693449
Report Number2518422-2017-00157
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1054260
Device Catalogue Number1054260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2014
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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