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

Model Number 1090670

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The manufacturer received information that a user of an amara view mask with magnet headgear has a contraindication and would like to know what is the next step.The user was advised to order the talon clip and given the part number for ordering from his provider.The user stated the provider does not have them and did not offer to order them.We gave the user an option with freedom link for another provider.The user would not give any additional information.Additional attempts to gain information were unsuccessful.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
• Type of Device: 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: 15931816
• MDR Text Key: 305000256
• Report Number: 2518422-2022-101178
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959009288
• UDI-Public: 00606959009288
• 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
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1090670
• Device Catalogue Number: 1090670
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES90705
• Patient Sequence Number: 1
• Patient Sex: Male