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

Model Number ICONAAA

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint icon cpap was not received at fisher & paykel healthcare (f&p) in (b)(4).Our investigation is accordingly based on the information and photograph provided by the customer.Results: visual inspection of the photograph revealed that the power cord had gross damage to the outer and inner insulation of the power cord, exposing copper wiring.Conclusion: the nature of the damage suggests the power cord may have been subjected to excessive force or sharp tools.The lot date confirms that the unit is almost two years old.During initial assembly of the icon cpap, all power cords are visually inspected for damage.Once the assembly process is completed, all icon cpap devices are visually inspected again before release for distribution.This suggests the damage occurred after it had been distributed.The icon cpap is designed to the electrical safety standards, ul60601-1 and as/nzs 3200.1.The materials used in the thermoplastic components of the mains connector and the cases are flame retardant according to ul 60601-1 and as/nzs 3200.1.Our user instructions that accompany the icon state the following: "only operate if the device, power cord and plug are dry and in good working order." "do not operate the device, water chamber or breathing tube if it is dropped, damaged or not working as intended.".

Event Description

A distributor in (b)(6) reported that an icon cpap humidifier had a damaged power cord.There was no patient involvement.

• Brand Name: ICON SERIES 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 dr., suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8158577
• MDR Text Key: 130176795
• Report Number: 9611451-2018-01032
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K094040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ICONAAA
• Device Catalogue Number: ICONAAA
• Device Lot Number: 2100124363
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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