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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE

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RESPIRONICS, INC TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040007
Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2017
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator's internal battery failed to hold its charge. The device was not in patient use. The device has yet to be returned to the manufacturer for evaluation. At this time, we are unable to confirm the alleged malfunction. A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
The manufacturer has completed the evaluation for a ventilator that the internal battery failed to hold it's charge. The device was evaluated at the manufacturer's service center and the customer's complaint was confirmed. The device's internal battery was replaced to address the issue.
 
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Brand NameTRILOGY 202
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin dr.
new kensington, PA 15068
7243349303
MDR Report Key6587350
MDR Text Key76029789
Report Number2518422-2017-01295
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 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1040007
Device Catalogue Number1040007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2014
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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