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

Model Number 1102666

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging that an elbow from a mask became disconnected, and the washer that surrounds the mask was found in the patient's pharynx.The washer was removed from the patient's pharynx by a physician, and no other serious injury or impairment was reported.The manufacturer has requested the return of the device to its product investigation lab for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported receiving information alleging that an elbow from a mask became disconnected, and the washer that surrounds the mask was found in the patient's pharynx.The washer was removed from the patient's pharynx by a physician, and no other serious injury or impairment was reported.The manufacturer received the device for evaluation and was unable to confirm the allegation.The mask was found to function as designed with no defects observed.The manufacturer is unable to determine the root cause of the complaint.

• Brand Name: COMFORTGEL BLUE FULL
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11958964
• MDR Text Key: 254882648
• Report Number: 2518422-2021-01695
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K073600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1102666
• Device Catalogue Number: 1102666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention