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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 10/26/2017
Event Type  malfunction  
Manufacturer Narrative
Device has been evaluated but the components have not been replaced pending customer approval of estimate.
 
Event Description
The manufacturer received information alleging a ventilator's internal battery failed to hold it's charge. There was no harm or injury reported. The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed. The device's internal battery and power management board need to be replaced 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 rd
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin dr.
new kensington, PA 15068
7243349303
MDR Report Key7027617
MDR Text Key92064768
Report Number2518422-2017-02572
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
Report Date 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2017
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 Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2014
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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