MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VITERA MASK FULL FACE LARGE A MODEL; BZD

Model Number VIT1LA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Sepsis (2067); Vomiting (2144)

Event Type  Injury  

Event Description

A patient reported that they vomited and subsequently aspirated some of the vomit, while wearing a vit1ma vitera full face mask.The patient reported they were hospitalized and has since recovered.The patient reports they often feel nauseous and has reflux often due to experiencing a hiatal hernia last year.Further information about the reported event has been requested.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of obtaining further information regarding the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A disabled patient reported that they vomited and subsequently aspirated some of the vomit while wearing a vit1ma vitera full face mask.The patient reported they became septic and was hospitalized but has since recovered.The patient reports they often feel nauseous and has reflux often due to experiencing a hiatal hernia last year.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) have made multiple attempts to obtain further information with regards to the reported event, however no further information was provided.Method: the complaint vit1ma vitera full face mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the initial information provided by the customer and our knowledge of the product.Results: a disabled patient reported that they vomited and subsequently aspirated some of the vomit, while wearing a vit1ma vitera full face mask.The patient reported they became septic and was hospitalized but has since recovered.The patient reports they often feel nauseous and has reflux often due to experiencing a hiatal hernia last year.Information reported by the customer did not indicate any failure with the device.Conclusion: without the return of the complaint device or further information from the customer, we are unable to determine the cause of the reported event.The instructions for use that accompany the vit1ma full face mask state the following under warnings: - "this mask must be used under qualified supervision for users whom are unable to remove the mask themselves" - do not use if vomiting or feeling nauseous" the customer stated that they found the relevant warnings in the instructions for use after the event had occurred.

• Brand Name: VITERA MASK FULL FACE LARGE A MODEL
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14846344
• MDR Text Key: 294904674
• Report Number: 9611451-2022-00517
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VIT1LA
• Device Catalogue Number: VIT1LA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization