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

Model Number SPSAAJ

Device Problems Component Missing (2306); Connection Problem (2900)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor in (b)(6) reported that a power pin from the power socket of a fisher & paykel healthcare (f&p) sleepstyle auto cpap humidifier was missing.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint sleepstyle auto cpap was received at our fisher & paykel healthcare (f&p) regional office in japan and was inspected by a trained f&p technician.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 japan reported that a power pin from the power socket of a fisher & paykel healthcare (f&p) sleepstyle auto cpap humidifier was missing.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
• MDR Report Key: 11346679
• MDR Text Key: 233802823
• Report Number: 9611451-2021-00198
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012445650
• UDI-Public: (01)09420012445650(10)2100528151(11)180710
• Combination Product (y/n): N
• PMA/PMN Number: K173193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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: 2100528151
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1