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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
Medical Device Problem Code Aborted Charge (2288)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/06/2017
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator failed to charge its internal battery.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the battery charging limit was found to be set to 65%.The device's battery charge limit was reset to 100% to correct the issue.
 
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Brand Name
TRILOGY 100
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key6442275
Report Number2518422-2017-00813
Device Sequence Number19226748
Product Code CBK
UDI-Device Identifier00606959033900
UDI-Public00606959033900
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K083526
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1054260
Device Catalogue Number1054260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2017
Initial Report FDA Received Date03/29/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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