MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD SIMPLUS FULL FACE MASK - MEDIUM; BZD

Model Number 400HC580

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher and paykel (f&p) are currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject 400hc580 simplus mask seal (medium) to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A patient's spouse reported on behalf of a patient in the usa that the 400hc580 simplus mask seal (medium) impacted the patient's jaw and affected the patient's teeth, and that the teeth are now overlapping.The patient's spouse stated that the patient has been using the 400hc580 simplus mask seal (medium) for the last five to seven years.It was reported that the patient has sought medical attention from a dentist and a specialist, however there was no medical intervention.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.

Event Description

A patient's spouse reported on behalf of a patient in the usa that the 400hc580 simplus mask seal (medium) impacted the patient's jaw and affected the patient's teeth, and that the teeth are now overlapping.The patient's spouse stated that the patient has been using the 400hc580 simplus mask seal (medium) for the last five to seven years.It was reported that the patient has sought medical attention from a dentist and a specialist, however there was no medical intervention.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.

Manufacturer Narrative

(b)(4).Method: the complaint 400hc580 simplus mask seal 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 our product.Results: the patient's spouse reported that the 400hc580 simplus mask seal impacted the patient's jaw and affected the patient's teeth, and that the teeth are now overlapping.The patient's spouse stated that the patient has been using the 400hc580 simplus mask seal for the last five to seven years.It was reported that the patient has sought medical attention from a dentist and a specialist, however there was no medical intervention.No further information was provided.Conclusion: initial details provided by the customer did not indicate any specific fault or malfunction with the 400hc580 simplus mask seal.Without the complaint device, we are unable to determine whether there were any faults with the device that may have caused or contributed to the reported event.Multiple attempts were made to obtain further information from the customer, however no additional information was received.Without further information, we are unable to determine the cause of the reported event.The user instructions that accompany the simplus full face mask provide information to ensure that the simplus full face masks are fitted and worn correctly, including the following: warnings: discontinue use if discomfort or irritation occurs, and consult your healthcare provider.Cautions: ensure the headgear is not overtightened.The mask, when correctly worn, should be able to be pulled away from the mouth without adjusting the straps or disconnecting the headgear clips.Fitting tips: do not over-tighten any of the headgear straps.

• Brand Name: SIMPLUS FULL FACE MASK - MEDIUM
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17102288
• MDR Text Key: 316949766
• Report Number: 9611451-2023-00522
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400HC580
• Device Catalogue Number: 400HC580
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2023
• 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