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

Model Number 1054260

Device Problems Break (1069); Failure to Power Up (1476); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device would not power on and the keypad could not be accessed as it was pushed inside the device.The connector between the device's system pca and front panel pca was realigned to address the issue.The device had physical damage consistent with being dropped.

Manufacturer Narrative

Initial report, 2518422-2015-01271, incorrectly indicated a death ocurred.The correct selection is malfunction.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): PHILIPS RESPIRONICS; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 1740 golden mile highway; monroeville 15146 ; 7243875658
• MDR Report Key: 4769199
• MDR Text Key: 5796682
• Report Number: 2518422-2015-01271
• Device Sequence Number: 1
• Product Code: CBK
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2010
• 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