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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 01/16/2017
Event Type  malfunction  
Event Description
A ventilator was returned to a third party service center for evaluation. The device was not in patient use. During the evaluation of the device at a third party service center, a failure of the device's internal battery to hold it's charge was observed. The ventilator's internal battery was replaced to address the issue.
 
Manufacturer Narrative
The manufacturer previously reported a third party service center replaced an internal battery. The internal battery was 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.
 
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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 Key6292428
MDR Text Key66238722
Report Number2518422-2017-00264
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 other
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2017
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2015
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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