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

Model Number	ICONAAJ
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint icon auto cpap humidifier is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor in (b)(6) reported that an icon auto cpap humidifier power cord was frayed.There was no reported patient involvement.
Additional 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 was frayed.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 occured 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/nzs 3200.1.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 or Problem Description
A distributor in canada reported that an icon auto cpap humidifier power cord was frayed.There was no reported patient involvement.

• Brand Name: ICON SERIES CPAP
• Common Device Name: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 11860969
• Report Number: 9611451-2021-00596
• Device Sequence Number: 4420729
• Product Code: BZD
• UDI-Device Identifier: 09420012425034
• UDI-Public: (01)09420012425034(10)2100355637(11)171110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K094040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: ICONAAJ
• Device Catalogue Number: ICONAAJ
• Device Lot Number: 2100355637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1