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

Model Number	1090201
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	01/21/2021
Type of Reportable Event	Death
Event or Problem Description
The manufacturer became aware that a user was being transferred via ambulance to her home for hospice care.The user was on a hospital bipap machine and mask and transferred to her own bipap with a new amara view full face mask for home usage.The ems personnel allegedly did not remove the clear plastic shroud/ liner from the mask before placing it on the user.In the following minutes, the user allegedly suffocated to death with all the medical personnel in the same room.It is unknown the type and manufacturer of the bipap machine and the settings of the device at the time of death.The investigation is on-going.A follow up final will be filed when the investigation is complete.
Event or Problem Description
The manufacturer became aware that a user was being transferred via ambulance to her home for hospice care.The user was on a hospital bipap machine and mask and transferred to her own bipap with a new amara view full face mask for home usage.The ems personnel allegedly did not remove the clear plastic shroud/ liner from the mask before placing it on the user.In the following minutes, the user allegedly suffocated to death with all the medical personnel in the same room.It is unknown the type and manufacturer of the bipap machine and the settings of the device at the time of death.The investigation is on-going.A follow up final will be filed when the investigation is complete.
Additional Manufacturer Narrative
Correction: the manufacturer previously reported on the initial mdr the medical device problem code: 3190 (insufficient information).After review, the medical device problem code should be 4001 (patient device interaction problem).The manufacturer also reported this on mdr 2518422-2022-13896 (medwatch report) and 2518422-2022-13896-1 as well.Additional new information was received on the mask model, catalog number and lot number.Udi was also given.The device model and sn was also new information.No product was returned for investigation.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.

• Brand Name: AMARA VIEW FULL FACE MASK
• Common Device Name: 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: 13607497
• Report Number: 2518422-2022-04685
• Device Sequence Number: 5857052
• Product Code: BZD
• UDI-Device Identifier: 00606959006508
• UDI-Public: 00606959006508
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1090201
• Device Catalogue Number: 1090201
• Device Lot Number: (10)82517628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DREAMSTATION BIPAP ST 30 J273194979506; HOME BIPAP MACHINE- NO SN
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female