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

Model Number ICONAAN

Device Problems Device Issue (2379); Cut In Material (2454)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint icon cpap was received at fisher & paykel healthcare in (b)(4) for evaluation.The icon cpap was inspected externally.Results: visual inspection revealed no signs of impact damage to the returned cpap.The power cord was grossly damaged and the power cord was observed to be cut.The device's hour meter read 8,135 hours, indicating it had been used for approximately 1,016 days (approximately 2.5 years).Conclusion: from the investigation conducted, the nature of the damage observed on the power cord suggests that it was cut.It is unknown how the cord became cut, however based on the number of hours used before a complaint was noted, the cut most likely occurred when in use by the customer.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 that an icon cpap humidifier had a damaged power cord.Upon investigation, it was confirmed that the power cord grommet was damaged.No patient 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: jonathan stevens ; 173 technology dr., suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6405298
• MDR Text Key: 70066971
• Report Number: 9611451-2017-00203
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICONAAN
• Device Catalogue Number: ICONAAN
• Device Lot Number: 130423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1