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

Model Number SPSCAA

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint sleepstyle cpap was not returned to fisher & paykel healthcare (f&p) for evaluation.The device was disposed by the customer.Our investigation is based on the photography and description of events provided by the customer, previous investigations of similar complaints, and our knowledge of the product.Results: visual inspection of the photo provided by the customer demonstrated that one of the power pins had been pulled out from the power 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 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".

Event Description

A healthcare facility in australia reported that the pins from the power socket of a sleepstyle cpap had snapped off.There was no reported patient involvement.

• Brand Name: SLEEPSTYLE 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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15755074
• MDR Text Key: 303322729
• Report Number: 9611451-2022-01046
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012445667
• UDI-Public: (01)09420012445667(10)2100593160(11)180925
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPSCAA
• Device Catalogue Number: SPSCAA
• Device Lot Number: 2100593160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female