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

Model Number SPSCAA

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Ps313582.The complaint f&p sleepstyle series cpap has recently arrived at fisher & paykel healthcare in (b)(4) for investigation.We will provide a follow-up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported that upon removing the power cord from the back of the f&p sleepstyle auto cpap, the power prong inside the unit has come apart and is stuck with the power cord.There was no known patient involvement and no user consequence.

Manufacturer Narrative

(b)(4).Method: the complaint f&p sleepstyle series cpap was received at fisher & paykel healthcare in new zealand and was visually inspected internally and externally.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 japan reported that upon removing the power cord from the back of the f&p sleepstyle auto cpap, the power prong inside the unit has come apart and is stuck with the power cord.There was no known 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: 8814057
• MDR Text Key: 152083540
• Report Number: 9611451-2019-00690
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012445650
• UDI-Public: (01)09420012445650(10)2100592135(11)180924
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• 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: 2100592135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1