MAUDE Adverse Event Report: RESPIRONICS, INC. L FITLIFE MASK EE W/HGR JPN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1075963

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Date 12/11/2017

Event Type  Death  

Event Description

The manufacturer received an allegation of a patient death due to inadvertent disconnection of the circuit and mask while using a trilogy ventilator and a fitlife total face mask in the home.The manufacturer has requested return of the fitlife mask and patient circuit for investigation.The trilogy device is not returning to the manufacturer.Upon completion of the manufacturer's investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer was informed that the mask and patient circuit are not available for investigation.No product has been returned.The patient is reported to have been restrained at times due to violent behavior, but it is unknown if the restraints were in place at the time of the event.Attempts to gather further information have been unsuccessful.The fitlife total face mask is intended to provide an interface for application of cpap or bi-level therapy to patients.This mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The small size mask is to be used on patients 7 years or older (>20 kg) for whom cpap or bi-level therapy has been prescribed.The large and extra-large size masks are to be used on patients (>30 kg) for whom cpap or bi-level therapy has been prescribed.This mask is not suitable for providing life support ventilation.This mask should not be used for patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask by themselves.Appropriate patient monitoring should be used as medically necessary.Based on the information available, the manufacturer is unable to confirm the complaint that the disconnection of the fitlife total face mask from the patient circuit caused or contributed to the reported event.No further action is required at this time.If further information becomes available regarding this reported event, a supplemental report will be filed.

• Brand Name: L FITLIFE MASK EE W/HGR JPN
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243349303
• MDR Report Key: 7130788
• MDR Text Key: 95309972
• Report Number: 2518422-2017-02933
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1075963
• Device Catalogue Number: 1075963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death