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

Model Number 1090622

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Eye Injury (1845)

Event Date 05/25/2022

Event Type  Injury  

Event Description

The manufacturer was made aware of an allegation by an end user that she developed "corneal erosion" in the past 6 months due to air blowing in her eyes during positive airway pressure (pap) therapy while using an amara view face mask.The user was reportedly prescribed unspecified eye drops and an ointment.The user has modified the mask by drilling holes in the bottom of it and refused the manufacturer's request that she notify her supplier.No part number or lot number have been provided.The manufacturer's investigation is ongoing.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously reported that an end user developed "corneal erosion" due to air blowing in her eyes during positive airway pressure (pap) therapy while using an amara view face mask.The user was reportedly prescribed unspecified eye drops and an ointment.The user modified the mask by drilling holes in the bottom of it and refused the manufacturer's request that she notify her supplier.The mask was returned to the manufacturer and the customer's complaint could not be confirmed.Though altered, the cushion was tested as received and did not leak.No airflow was detected in the eye area of the test setup mannequin.The investigation findings did not uncover any details that would change or modify the risk of the device.The product investigation laboratory observed three holes in the chin area of the cushion that were not of original design.Gauze tape was covering up the non-original holes.The rest of the cushion was damage and defect free and was of original design orientation.Due to the customer altering the cushion's original design, this product no longer meets philips respironics compliance and specifications.The amara full face mask is intended to provide an interface for application of cpap or bi-level therapy to patients.The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment.The mask is to be used on patients (>66lbs/30kg) for whom cpap or bi-level therapy has been prescribed.This mask should also not be used on patients who need life support ventilation, who are taking prescription medication that may cause vomiting, or on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask.An exhalation port is built into the mask so a separate exhalation port is not required.Amara view minimal contact full face mask ifu provides instructions to check the mask and cushion before use as well as instructions on mask sizing.1109349 provides instructions for the user to discontinue use if eye irritation occurs.In addition, contraindications state that the mask may not be suitable for use on patients with recent eye surgery or dry eyes.The manufacturer could not determine the root cause for the complaint and concludes no further action is necessary.

Manufacturer Narrative

Correction to the initial report 2518422-2022-42114 , section h-6 medical device problem code 3190 insufficient information was chosen.The correct selection is patient device interaction problem code-4001.

• 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: 14679035
• MDR Text Key: 293883923
• Report Number: 2518422-2022-42114
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959009196
• UDI-Public: 00606959009196
• 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,Followup,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1090622
• Device Catalogue Number: 1090622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female