MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC AMARA VIEW FULL FACE MASK

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

User is still wearing mask, getting replacement clips instead of magnets.

Event Description

The manufacturer was made aware that a user alleges her loop recorder for her heart has stopped recording.The user states she has not been getting a reading and believes the magnets in her mask may be why it is not working.The user wears an amara view mask with magnetic headgear while using her pap device for her sleep apnea.The user has requested replacement clips for her headgear.There was no patient harm or injury reported, no reported medical intervention.No mask is returning for investigation.The user is still wearing her mask.\ 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
• Type of Device: 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: 15890444
• MDR Text Key: 304975301
• Report Number: 2518422-2022-100723
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female