MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AMARA VIEW FULL FACE MASK; CPAP/BIPAP FULL FACE MASK

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	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for investigation.
Event or Problem Description
The manufacturer received information that a user of an amara view mask with magnet headgear alleges the mask with magnets has reduced the lifetime of his defibrillator by 1.5 years.The user stated the defibrillator was making a sound like an alarm for thirty seconds or more.The user was instructed to order the non magnetic clips for his mask and headgear.There was no report of patient harm or injury.No product was returned for investigation.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.

• Brand Name: AMARA VIEW FULL FACE MASK
• Common Device Name: CPAP/BIPAP FULL FACE MASK
• 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: 15936333
• Report Number: 2518422-2022-101259
• Device Sequence Number: 17694640
• Product Code: BZD
• UDI-Device Identifier: 00606959009288
• UDI-Public: 00606959009288
• Combination Product (Y/N): N
• 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: Other
• 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: 11/10/2022
• Initial Report FDA Received Date: 12/07/2022
• 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 Sex: Male