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

Model Number ICONAAN-HT

Device Problems Break (1069); Mechanical Problem (1384); Scratched Material (3020)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

A distributor in (b)(4) reported, via a fisher & paykel healthcare (f&p) field representative, that the power cord of an icon cpap humidifier was damaged and had exposed copper wires.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).We have requested the return of the complaint icon cpap humidifier for investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint icon auto cpap humidifier was not returned to fisher & paykel healthcare (f&p) new zealand for evaluation.Our investigation is based on the photography and description of events provided by the customer, previous investigations of similar complaints and our knowledge of the product.Results: visual inspection of the photography provided by the customer demonstrated a chewed power cord.However no copper wires were visible.Conclusion: the power cord was chewed by an animal.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 reported by the customer 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 distributor in canada reported, via a fisher & paykel healthcare (f&p) field representative, that the power cord of an icon cpap humidifier was damaged and had exposed copper wires.It was also reported that the power cord had been damaged by a pet.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 ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14282899
• MDR Text Key: 294660074
• Report Number: 9611451-2022-00425
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 09420012425027
• UDI-Public: (01)09420012425027(10)2100188922(11)170404
• 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,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ICONAAN-HT
• Device Catalogue Number: ICONAAN-HT
• Device Lot Number: 2100188922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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