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

Model Number ICONPBN-HT

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint icon auto cpap humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the power cord had been damaged with exposed copper wires.Conclusion: without the complaint device, we are unable to confirm the reported event.During initial assembly of the icon auto cpap, all power cords are visually inspected for damage.Once the assembly process is completed, all icon auto cpap devices are visually inspected again before release for distribution.This suggests the damage occurred after it had been distributed.The icon auto 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/nzs3200.1.Our user instructions that accompany the icon auto cpap humidifier 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 canada, reported that the power cord of an icon cpap humidifier had been damaged with exposed copper wires.There was no reported patient harm.

• Brand Name: ICON PREMO
• Type of Device: CPAP
• 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine 92618 ; 8007923912
• MDR Report Key: 18790708
• MDR Text Key: 336990513
• Report Number: 9611451-2024-00120
• 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: Foreign,Consumer,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 2100321123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2017
• 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