MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1054260

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2017

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator failed to hold its internal battery charge.The device was not in patient use.The ventilator was returned to the manufacturer for evaluation and error codes related to the charging of the internal battery was observed.The device's internal battery and power management board were replaced to address the issues.

Manufacturer Narrative

The manufacturer previously reported an issue with the internal battery and power management board.The internal battery and power management board were returned to the manufacturer's quality assurance laboratory for further investigation.During the investigation the root cause of the internal battery not charging was found to be due to a.5vdc cell imbalance.The power management board was evaluated by the manufacturer's quality assurance laboratory and was found to operate to design specifications.

• 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; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 6275743
• MDR Text Key: 65693449
• Report Number: 2518422-2017-00157
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: 00606959015364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1