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

Model Number ICONAAN

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the consumer.We will provide a follow up report upon completion of our investigation.

Event Description

A consumer reported that the power cord of an icon cpap humidifier had "exposed wires".There was no patient involvement, and no user consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint icon cpap was not returned tot fisher & paykel healthcare (f&p) for evaluation.We were not able to retrieve any further information from the customer.Our investigation is thus based on the event description and our knowledge of the product.Results: the customer reported that the power cord had "exposed wires".Conclusion: without the complaint device it is not possible to confirm the fault, or to determine what caused the alleged malfunction.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 consumer reported that the power cord of an icon cpap humidifier had "exposed wires".There was no patient involvement, and no user consequence was reported.

• 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
• MDR Report Key: 8602556
• MDR Text Key: 145112878
• Report Number: 9611451-2019-00470
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K094040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/13/2019

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: ICONAAN
• Device Catalogue Number: ICONAAN
• Device Lot Number: 150217
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1