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

Model Number SPSCAA

Device Problems Disconnection (1171); Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint sleepstyle series 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.Due to the covid-19 pandemic, causing operational disruption at our f&p (b)(4) regional facility, this reported event was notified to f&p (b)(4) on 21 august 2020 and promptly reported to fda at the first availability as per fda guidance titled "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic, (may 2020).".

Event Description

A distributor in (b)(4) reported that a f&p sleepstyle auto cpap is not working properly.It was further reported that a pin from the power socket of the f&p sleepstyle auto cpap was stuck in the power cord.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint f&p sleepstyle auto cpap was received at fisher & paykel healthcare in new zealand and was visually inspected.Results: visual inspection confirmed 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 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 australia reported that a f&p sleepstyle auto cpap is not working properly.It was further reported that a pin from the power socket of the f&p sleepstyle auto cpap was stuck in the power cord.There was no reported patient 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
• MDR Report Key: 10452500
• MDR Text Key: 206136114
• Report Number: 9611451-2020-00723
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012445667
• UDI-Public: (01)09420012445667(10)2100527136(11)180709
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 2100527136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1