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

Model Number SPSAAJ

Device Problems Mechanical Problem (1384); Connection Problem (2900)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) have requested for the return of the subject sleepstyle for evaluation.We will provide a follow-up report upon completion of our investigation.Our user instructions that accompany the f&p sleepstyle state the following: - "do not use if the device, power cord or accessories are damaged, deformed, or cracked." - "do not pull on the power cord as it may become damaged." - "turn the device off at the power supply, then remove the power cord from the rear of the device.".

Event Description

A distributor in japan reported via a fisher & paykel healthcare field representative that a sleepstyle cpap had been dropped and that the power socket had been dislodged.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint sleepstyle cpap was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the sleepstyle cpap confirmed that the power socket had dislodged from its position.There were no exposed wires and the electric pins were intact and not damaged.The customer also reported that the subject device had been dropped.There was no reported patient use at the time of event.Conclusion: f&p could not determine a definitive root cause for the reported event.However, based on our knowledge of the product and investigation, possible contributing causes include excessive force applied to the device when it was dropped and a change in material strength due to material processing in the supplied power plug socket.Due to previous design changes, f&p no longer sources the plug sockets for the sleepstyle cpaps from the same supplier as the complaint sleepstyle cpap.Our user instructions that accompany the f&p sleepstyle state the following: "do not use if the device, power cord or accessories are damaged, deformed, or cracked." do not pull on the power cord as it may become damaged." "turn the device off at the power supply, then remove the power cord from the rear of the device." there have been no other similar failures from the lot number of the complaint sleepstyle cpap (lot: 2100929995).

Event Description

A distributor in japan reported via a fisher & paykel healthcare field representative that a sleepstyle cpap had been dropped and that the power socket had been dislodged.There was no reported patient involvement.

• Brand Name: SLEEPSTYLE CPAP
• Type of Device: CPAP
• 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: 17837764
• MDR Text Key: 324582726
• Report Number: 9611451-2023-00915
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012445650
• UDI-Public: (01)09420012445650(10)2100929995(11)191106
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPSAAJ
• Device Catalogue Number: SPSAAJ
• Device Lot Number: 2100929995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• 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