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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 Problems Premature Discharge of Battery (1057); Failure to Charge (1085); Battery Problem (2885)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator's internal battery fails to hold a 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 previously reported a ventilator's internal battery failed to hold a charge. The device was not in patient use. The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed. The device's internal battery was replaced to address the issue. Evaluation conclusion
=
device has been evaluated but not repaired, pending customer approval of the estimate.
 
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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, INC
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key7285585
MDR Text Key100652802
Report Number2518422-2018-00439
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 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
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 Manufacturer02/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2009
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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