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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 1054096
Device Problems Failure to Charge (1085); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, an error code related to the charging of the internal battery was observed.The device's internal battery needs replaced to address the issue.
 
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Brand Name
TRILOGY 100
Type of Device
VENTILATOR, 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 Key11731494
MDR Text Key247481903
Report Number2518422-2021-01200
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022805
UDI-Public00606959022805
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Date Manufacturer Received04/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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