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

Model Number	1090624
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Angina (1710)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hhe - patient interface magnet hhe er 2242274 page 15 section 3: health risks states, "all magnet masks contained a warning against having the magnet mask within 2 inches of any active medical implant or medical device that can be impacted by the magnetic field.".
Event or Problem Description
The manufacturer received information from the patient with allegation of chest pain while using his amara view mask magnet.Patient stated while he was asleep, he started having chest pain, with his neck on his shoulders.The patient did not seek medical intervention the next day, but had prior to, and the doctor stated the mask magnets had interfere with his stints.The patient alleges that he is sluggish and tired because of the chest pain.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer.This report is being sent to conclude that no further investigation is possible.No device has been returned.No further evaluation is possible at this time.Despite three good faith-effort attempts on (07/22/2025), (07/25/2025), and (08/07/2025) to +1(832)283-7991 to have the device returned for evaluation and investigation were unsuccessful.Section in box h has been updated/corrected in this report.

• Brand Name: AMARA VIEW
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22460382
• Report Number: 2518422-2025-107196
• Device Sequence Number: 15598096
• Product Code: BZD
• UDI-Device Identifier: 00606959009219
• UDI-Public: (01)00606959009219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 1090624
• Device Catalogue Number: 1090624
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1783-2022.
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male