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

Model Number SPSAAN

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint f&p sleepstyle series cpap was received at fisher & paykel healthcare in (b)(4) and was visually inspected internally and externally.Results: visual inspection showed that one pin had detached 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 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 healthcare facility in (b)(6) reported a fault with an fisher & paykel healthcare (f&p) sleepstyle.Upon evaluation of the device, it was discovered that a pin from the mains inlet socket had come apart.There was no patient involvement and no user consequence.

• Brand Name: F&P 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 ; 8007923912
• MDR Report Key: 9121484
• MDR Text Key: 176480378
• Report Number: 9611451-2019-00922
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012437068
• UDI-Public: (01)09420012437068(10)2100581800(11)180912
• 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,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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: 2100581800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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