MAUDE Adverse Event Report: RESPIRONICS, INC. AMARA VIEW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1090602

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Partial Hearing Loss (4472)

Event Date 11/14/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an end user with ear implants experienced hearing loss while using the amara view face mask with magnetic clips.The user allegedly used the mask for two years and noticed a decline in his hearing.The care facility for patient care has changed the mask to one without magnets.No product will be returned for investigation.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.

• Brand Name: AMARA VIEW MASK
• 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 ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15835518
• MDR Text Key: 304032920
• Report Number: 2518422-2022-94792
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959009134
• UDI-Public: 00606959009134
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1090602
• Device Catalogue Number: 1090602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other