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

Model Number SPSAAN

Device Problems Break (1069); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint sleepstyle auto cpap is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4), reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a power pin from the power socket of a fisher & paykel healthcare (f&p) sleepstyle auto cpap was broken.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint sleepstyle auto cpap was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the sleepstyle auto cpap confirmed that one power pin was missing from the mains inlet socket.Conclusion: the reported incident was traced to an issue in the assembly process of the supplied mains inlet connector component.The supplier of the component was notified and they have made changes to the assembly process.As part of our ongoing product improvement initiatives, we recently implemented a gauge test which identifies and rejects any potentially faulty mains inlet sockets prior to assembly into 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.".

Event Description

A distributor in canada, reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a power pin from the power socket of a fisher & paykel healthcare (f&p) sleepstyle auto cpap was broken.There was no reported patient involvement.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12715154
• MDR Text Key: 282562602
• Report Number: 9611451-2021-01196
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012437068
• UDI-Public: (01)09420012437068(10)2100594238(11)180926
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2100594238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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