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

Model Number ICONPBN-HT

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 occured 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 healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an icon cpap humidifier had a damaged power cord.There was no reported 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 ; 4534000142
• MDR Report Key: 10084534
• MDR Text Key: 193951063
• Report Number: 9611451-2020-00494
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K094040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2020

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: ICONPBN-HT
• Device Catalogue Number: ICONPBN-HT
• Device Lot Number: 130712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2013
• 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