MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AMARA VIEW MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1090670
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware that a user of an amara view mask with magnetic headgear alleges his heart beat fluctuates and he now believes that it could be due to his mask.User has had three defibrillators since 2015.The most recent replacement was two years ago in 2020.User does not think the magnets affected his defibrillator.The dme has sent the user clips and for several days it worked fine.Now his cpap quit working which is over five years old, so user is getting his machine replaced at the dme.There was no serious harm or injury reported.No mask or headgear will be returning.User now has clips and will continue using the mask and headgear with clips.This will be an initial-final report.The manufacturer will continue to monitor complaints for similar issues.The manufacturer concludes no further action is needed at this time.
Additional Manufacturer Narrative
No product returned for investigation.

• Brand Name: AMARA VIEW MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16013335
• Report Number: 2518422-2022-102493
• Device Sequence Number: 15104288
• Product Code: BZD
• UDI-Device Identifier: 00606959009288
• UDI-Public: 00606959009288
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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

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: 1090670
• Device Catalogue Number: 1090670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: RES90705
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male