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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 Aborted Charge (2288)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  Malfunction  
Event Description

The manufacturer received information alleging a ventilator was not charging its battery to full capacity. There was no harm or injury reported. The ventilator was returned to the third party service center and the customer's complaint was confirmed. The device's battery charge limit was reset 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 Key9596001
MDR Text Key175226165
Report Number2518422-2020-00140
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1054260
Device Catalogue Number1054260
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/02/2017
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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