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

Model Number 1090604

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 11/02/2022

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation that a user of the amara view full face mask with headgear magnets was experiencing pain in his neck where his metallic disc and joint implant is located.After receiving the safety notice 2022-cc-src-001, the user stopped using this mask with headgear and the pain disappeared.The user was then diagnosed with cancer and his doctor does not exclude the possibility that both the pain and cancer diagnosis could be related to the use of the mask.The manufacturer has requested the mask to be returned for investigation.To date, no mask has been returned.The investigation is on-going.A follow up final will be submitted when the investigation is complete.

Manufacturer Narrative

The manufacturer became aware of an allegation that a user of the amara view full face mask with headgear magnets was experiencing pain in his neck where his metallic disc and joint implant is located.After receiving the safety notice 2022-cc-src-001, the user stopped using this mask with headgear and the pain disappeared.The user was then diagnosed with cancer and his doctor does not exclude the possibility that both the pain and cancer diagnosis could be related to the use of the mask.The manufacturer requested the return of the mask for investigation.No product was returned.The reported event of cancer and its reported severity was reviewed by the pms clinical expert.This event is assessed as not related to the product in this case.When used and cleaned properly and as recommended in the product ifu, it is not reasonably possible for exposure to the silicone of the mask and/or the magnets to create cancerous cells or unregulated proliferation of cancer cells.The amara view face mask instructions for use will include 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 6 inches (approx.15.24 cm) 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.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 FULL FACE 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: 15774181
• MDR Text Key: 303533337
• Report Number: 2518422-2022-92661
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959009158
• UDI-Public: 00606959009158
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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: 1090604
• Device Catalogue Number: 1090604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/04/2023
• 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
• Removal/Correction Number: RES90705
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male