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

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Respiratory Arrest (4461)

Event Date 01/23/2021

Event Type  Death  

Event Description

The manufacturer received information alleging an amara full face mask contributed to death of a end user.The mask was reportedly taken out of the packaging and placed on the end user by a health care professional with the protective covering still attached to the mask which led to desaturation and asphyxia.The manufacturer's investigation is ongoing.A follow up report will be submitted upon completion of the manufacturer's investigation.

Manufacturer Narrative

The manufacturer requested lot number and part number of the mask, but no information was available.No product was returned.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.The manufacturer concludes no further action is necessary.

Manufacturer Narrative

The manufacturer previously reported medical device problem code: 3190 (insufficient information).After review, the medical device problem code should be 4001 (patient device interaction problem).The manufacturer previously reported this on mdr 2518422-2022-04685 as well.

• Brand Name: AMARA 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: 14193079
• MDR Text Key: 289966903
• Report Number: 2518422-2022-13896
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• 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: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death