MAUDE Adverse Event Report: RESPIRONICS, INC. M COMFORTGEL BLUE FULL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1102665

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 09/30/2023

Event Type  Death  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

Philips received notification of an alleged patient death.Reporter stated ¿patient was taken to a hospital by ambulance.Patient was on a asv in the hospital and using a non-vent mask.The reported stated the user received error message stating ¿it is a non vent mask, please use with vent mask or eliminate occlusion, and alarm unit fault¿ while using the other manufacturers device with a philips non-vent mask, the patient suffered a cardiac arrest and passed.¿ no anomaly was seen on the appearance of the mask.Additional information has been requested but not yet received.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: M COMFORTGEL BLUE FULL
• 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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17952852
• MDR Text Key: 325895533
• Report Number: 2518422-2023-26628
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1102665
• Device Catalogue Number: 1102665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR
• Patient Sex: Male