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

Model Number	ICONPBN-HT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in canada, reported that the power cord of an icon cpap humidifier has cracked with exposed copper wires.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(6).Method: the complaint icon 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 cracked with exposed copper wires.Conclusion: without the complaint device, we are unable to confirm the reported event.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 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." iconpbn is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for the similar product is k094040.

• Brand Name: ICON PREMO
• Common Device Name: 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine 92618 ; 9494341005
• MDR Report Key: 20741663
• Report Number: 9611451-2024-00784
• Device Sequence Number: 8649182
• Product Code: BZD
• UDI-Device Identifier: 09420012425034
• UDI-Public: (01)09420012425034(10)2100270528(11)170721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: ICONPBN-HT
• Device Catalogue Number: ICONPBN-HT
• Device Lot Number: 2100270528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown