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

Model Number SPSCAA

Device Problems Material Separation (1562); Connection Problem (2900); Mechanical Jam (2983)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Event Description

A distributor in australia reported that the pins from the power socket of a sleepstyle auto cpap was found to come apart and stuck in the mains inlet socket.The fault was discovered when a distributor felt a strong thump through the hand as they plugged the machine in.No medical intervention was required.There was no further patient consequence.

Manufacturer Narrative

(b)(4).The complaint sleepstyle auto cpap is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint sleepstyle cpap was received at fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the sleepstyle cpap confirmed that both pins were pulled out from the mains inlet socket and in the power cord.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 distributor in australia reported that the pins from the power socket of a sleepstyle cpap was found to come apart and stuck in the mains inlet socket.The fault was discovered when a distributor felt a strong thump through the hand as they plugged the machine in.No medical intervention was required.There was no further patient consequence.

• 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: 14703178
• MDR Text Key: 296749162
• Report Number: 9611451-2022-00501
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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