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

Model Number	1090603
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation that an amara view face mask interfered with a users pacemaker due to the magnetic clips.The end user experienced a change in his heartbeat which resolved once the mask was removed.There was no report of medical intervention.There was no report of patient harm or injury.The manufacturer has not received the product for investigation.The amara view instructions for use includes the following warnings: the mask assembly contains magnets.Some medical devices may be affected by magnetic fields.The magnetic clips in this mask should be kept at least 2 in.(50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.Do not use in or near magnetic resonance imaging (mri) equipment.Keep unassembled magnetic headgear clips out of reach of children.In case of accidental swallowing, seek medical assistance immediately.This report will be filed as an initial-final report.We will continue to monitor these complaints regarding magnets.If any additional information is received, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• Brand Name: AMARA VIEW MASK
• Common Device Name: 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: 15033064
• Report Number: 2518422-2022-60534
• Device Sequence Number: 15183337
• Product Code: BZD
• UDI-Device Identifier: 00606959009141
• UDI-Public: 00606959009141
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1090603
• Device Catalogue Number: 1090603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown