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

Model Number 400476

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Insufficient Information (4580)

Event Date 02/15/2023

Event Type  Injury  

Event Description

Fisher & paykel healthcare (f&p) was informed on (b)(6) 2023 of an event in which a patient made a complaint about the simplus full face mask and sleepstyle auto cpap to a regulatory body in japan.The patient reported an inappropriate mask fit of the simplus full face mask and reported that they experienced a paroxysmal supraventricular tachycardia (psvt) attack and required a visit to the hospital.The patient's family also reported that the patient had a history of psvt.On (b)(6) 2023, the distributor reported that the simplus full face mask was leaking prior to the patient's psvt attack.The distributor stated that the patient had to stop using the mask and that the mask was replaced.The distributor also reported that the sleepstyle auto cpap was not providing sufficient pressure and that the patient has now recovered.F&p is currently trying to obtain further information on the causal relationship between the subject devices and the patient's psvt attack, and information surrounding the reported event.F&p has also requested the return of the simplus full face mask and sleepstyle auto cpap.

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event.F&p has also requested the return of the subject simplus full face mask and sleepstyle auto cpap to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.Device a - simplus full face mask; batch number: not provided.Device b - sleepstyle auto cpap; batch number: 2102140408, serial number: (b)(4), date of manufacturing: 20 apr 2022, udi: (b)(4).

Manufacturer Narrative

(b)(4).Method: the complaint simplus full face mask and sleepstyle auto cpap were returned to fisher & paykel healthcare (f&p) in new zealand.The simplus full face mask was visually inspected for defects and damages, and the mask exhaust flow was tested by creating an airtight block around the facial silicone seal and connecting the mask to an active cpap device.The flow from the exhaust holes of the mask was then measured.The sleepstyle auto cpap was visually inspected internally and externally for defects and damages, and a pressure test was performed.The compliance data of the sleepstyle auto cpap was also downloaded for review.Our investigation is based on information provided by the customer, our evaluation of the complaint devices, a clinical opinion from an independent medical expert, and our knowledge of the product.Results: the distributor informed f&p that the simplus full face mask had a poor fit and a leak, and that the sleepstyle auto cpap was not providing sufficient pressure.The distributor also reported that the patient experienced a paroxysmal supraventricular tachycardia (psvt) attack and that the patient had a history of psvt.The visual inspection of the simplus full face mask identified no defects or damages that would cause or contribute to a poor fit and a leak.The exhaust flow was found to also be within specification.The simplus full face mask is a prescription only device.A patient is to be prescribed the appropriate size and should be fitted with the guidance of a healthcare professional.The user instructions provided with the simplus full face mask contain tips and instructions on fitting the mask.The visual inspection of the sleepstyle auto cpap internally and externally revealed no defects or damages which may have caused or contributed to the device not delivering sufficient pressure.Pressure test performed on the sleepstyle auto cpap determined the device to be delivering the correct pressure.The review of the device's compliance log showed that mask leaks occurred and the size of the leak may impact the pressure being delivered.A clinical opinion was obtained from an independent medical expert by f&p with respect to this incident.Based on the information available including analysis of the data from the device itself and the available information regarding the relationship between osa and psvt in the clinical literature, the medical expert indicated that the cardiac arrhythmia in this patient appears to be a comorbid condition rather than an event caused by the operation of the devices.Conclusion: based on the results of the complaint device investigation there were no faults identified with the devices and the simplus full face mask size was found to be within specification.The sleepstyle auto cpap compliance log showed a history of mask leaks during therapy.It is likely that the mask leaks occurred due to a poor mask fit and the insufficient pressure from the cpap resulted due to the excessive mask leak in the system.The clinical opinion obtained from the independent medical expert revealed that it is likely that the patient's cardiac arrhythmia is not related to the use of the simplus full face mask and sleepstyle auto cpap and most likely is a result of a comorbid condition.The use and care guide supplied with the sleepstyle auto cpap state the following: warnings: to avoid incorrect therapy: refer to the mask's use and care guide prior to use to ensure correct fit of the mask.Incorrect fit of the mask may affect consistent operation of the device.The simplus full face mask is a prescription only device and should be fitted with the guidance of a healthcare professional.The healthcare professionals have a sizing guide that was supplied to them by f&p.The user instructions provided with the simplus full face mask contain tips and instructions on fitting the mask.Section d4: device a - simplus full face mask; lot number: not provided device b - sleepstyle auto cpap; lot number: 2102140408, serial number: (b)(4), date of manufacturing: 20 apr 2022, udi: (b)(4).

Event Description

Fisher & paykel healthcare (f&p) was informed on 1 march 2023 of an event in which a patient made a complaint about the simplus full face mask and sleepstyle auto cpap to a regulatory body in japan.The patient reported an inappropriate mask fit of the simplus full face mask and reported that they experienced a paroxysmal supraventricular tachycardia (psvt) attack and required a visit to the hospital.The patient's family also reported that the patient had a history of psvt.On 23 march 2023, the distributor reported that the simplus full face mask was leaking prior to the patient's psvt attack.The distributor stated that the patient had to stop using the mask and that the mask was replaced.The distributor also reported that the sleepstyle auto cpap was not providing sufficient pressure and that the patient has now recovered.No further information was provided.

• Brand Name: SIMPLUS FULL FACE MASK - SMALL
• 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 gomaroo ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 16652904
• MDR Text Key: 312406318
• Report Number: 9611451-2023-00287
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 400476
• Device Catalogue Number: 400476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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
• Treatment: F&P SLEEPSTYLE AUTO CPAP; SLEEPSTYLE AUTO CPAP
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR