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

Model Number SPSAAA

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event.We have also requested the return of the subject power cord of the sleepstyle auto cpap to f&p new zealand for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in australia reported that the electrical socket pins of a sleepstyle auto cpap was broken.There was no report of patient harm.

Event Description

A distributor in australia reported that the one of the pins from the power socket of a sleepstyle cpap was found to be stuck in the main inlet socket of the power cord and that the sleepstyle auto cpap cannot be used.There was no report of patient harm.

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) of a sleepstyle cpap.Conclusion: the reported incident was traced to an issue in the assembly process of the supplied mains inlet socket.The supplier of the mains inlet sockets was notified, and they had made changes to the assembly process.As part of our ongoing product improvement initiatives, a gauge test was implemented which identifies and rejects any potentially faulty mains inlet sockets during the assembly of the sleepstyle.The subject sleepstyle 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".

• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 16943763
• MDR Text Key: 315378296
• Report Number: 9611451-2023-00452
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012442956
• UDI-Public: (01)09420012442956(10)2100527432(11)180710
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: 2100527432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• 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