MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD SLEEPSTYLE AUTO CPAP; BZD

Model Number SPSAAN

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Event Description

A distributor in canada reported that the power inlet of a sleepstyle auto cpap had been pulled out from the device.There was no reported patient harm.

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 sleepstyle auto cpap to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Section h4 was corrected.The year of manufacture was changed from 2017 to the correct date, 2020.Method: the subject sleepstyle auto cpap was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Our investigation is based on the information provided by the customer, our own investigation, and our knowledge of the product.Results: visual inspection showed that the power socket was damaged due to excessive force or as if the device had been dropped from an excessive height.Conclusion: we are unable to determine the cause of the reported event.However, based on our knowledge of the product, and our observations of the returned product, the reported event was likely caused by excessive force, or the device being dropped from an excessive height.

Event Description

A distributor in canada reported that the power inlet of a sleepstyle auto cpap had been pulled out from the device.There was no reported patient harm.

Event Description

A distributor in canada reported that the power inlet of a sleepstyle auto cpap had been pulled out from the device.There was no reported patient harm.

Manufacturer Narrative

(b)(4).Method: following the initial investigation of the subject sleepstyle auto cpap, the complaint plug socket of the sleepstyle auto cpap was sent for further analysis using fourier transform infrared spectroscopy (ftir) to confirm the material type of the socket and differential scanning calorimetry (dsc) to analyse its material properties.This analysis was performed on the plug socket of the complaint sleepstyle auto cpap and plug sockets from two different lot numbers as reference sample for comparison purposes.Results: visual inspection of the complaint device revealed signs of water ingress on the user interface board.Ftir analysis confirmed that the complaint sleepstyle auto cpap and the reference plug sockets were made of the same material, polycarbonate.The dsc analysis showed that the material strength was less than the reference material.Conclusion: although fisher & paykel healthcare couldn't determine a definitive root cause, possible contributing causes considered include damage due to excessive force, cleaning procedures not being followed, and a change to material strength due to material processing.The plug socket used in the sleepstyle auto cpap is an externally sourced component.Due to previous design changes, fisher & paykel healthcare no longer sources the plug sockets for the sleepstyle auto cpaps from the same supplier as the complaint sleepstyle auto cpap.The current failure rate for this issue to date is (b)(4).There have been no other similar failures from the lot number of the complaint sleepstyle auto cpap (lot: 2100995597).There have also been no injuries related to reported failure.Fisher & paykel healthcare will continue to monitor for similar complaints and reassess upon receipt of new information.

• Brand Name: SLEEPSTYLE AUTO CPAP
• 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: 14951723
• MDR Text Key: 296857283
• Report Number: 9611451-2022-00561
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012437068
• UDI-Public: (01)09420012437068(10)2100995597(11)200130
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPSAAN
• Device Catalogue Number: SPSAAN
• Device Lot Number: 2100995597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2020
• 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