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

Model Number	1090604
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an amara mask caused a patient to have a cerebrospinal fluid leak due to the mask pushing on his nasal bone.The patient required surgery in response to the alleged event.The manufacturer has requested the return of the mask for evaluation, but the device has not yet been received.At this time, we are unable to confirm the allegation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging an amara mask caused a patient to have a cerebrospinal fluid leak due to the mask pushing on his nasal bone.The patient required surgery in response to the alleged event.The mask was returned to the manufacturer's quality product investigation lab for evaluation, and the customer's allegation was unable to be confirmed.An evaluation of the mask revealed signs of the mask being overtightened when in use, including excessive wear and stretching of the headgear that is associated with the device.This 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.Product labeling warns users: "do not overtighten the headgear straps.Watch for signs of overtightening, such as excessive redness, sores or bulging skin around the edges of the mask.Loosen the headgear straps to alleviate symptoms." based on the information available, the manufacturer concludes no further action is required.

• Brand Name: AMARA VIEW MASK
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11657269
• Report Number: 2518422-2021-01070
• Device Sequence Number: 19712952
• Product Code: BZD
• UDI-Device Identifier: 00606959009158
• UDI-Public: 00606959009158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1090604
• Device Catalogue Number: 1090604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR