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

Model Number SPSAAA

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

A distributor in australia reported that a pin from the power socket of a sleep style auto was found to be stuck in the power cord and the other pin is loose in the socket.There was no reported patient harm.

Manufacturer Narrative

(b)(4) fisher & paykel healthcare (f&p) have requested for the return of the subject sleepstyle to f&p new zealand for evaluation.We will provide a follow-up report upon completion of our investigation.

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 one of the pins was pulled out from the mains inlet socket (power socket).Conclusion: the reported event was traced to an issue in the assembly process of the supplied mains inlet connector component.The component supplier has since implemented changes to the assembly process and f&p healthcare also introduced a gauge test to identify and reject any potentially faulty mains inlet sockets during the assembly of the sleepstyle devices.Our investigation confirmed that the subject sleepstyle device was manufactured prior to implementation of these measures.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 australia reported that a pin from the power socket of a sleepstyle auto was found to be stuck in the power cord and the other pin is loose in the socket.There was no reported patient harm.

• Brand Name: SLEEPSTYLE AUTO
• 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: 18637667
• MDR Text Key: 334621678
• Report Number: 9611451-2024-00042
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPSAAA
• Device Catalogue Number: SPSAAA
• Device Lot Number: 2100593446
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2018
• 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