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

Model Number	ICONNAN-HT
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).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.
Event or Problem Description
A distributor in canada reported that the power cord of an icon cpap humidifier was damaged and had exposed copper wires.There was no reported patient involvement.
Event or Problem Description
A distributor in canada reported that the power cord of an icon cpap humidifier was damaged and had exposed copper wires.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint icon auto cpap humidifer was received at fisher & paykel healthcare (f&p) new zealand for evaluation and was visually inspected.Results: visual inspection showed that the power cord had been taped up.The tape was removed and showed that the wires were exposed and had been soldered, as if a repair had been done.Conclusion: the power cord may have been subjected to excessive force, causing the reported damage.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 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 ul60601-1 and as/nzs 3200.1.Our user instructions that accompany the sleepstyle 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".

• 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
• 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: 14518980
• Report Number: 9611451-2022-00499
• Device Sequence Number: 5309900
• Product Code: BZD
• UDI-Device Identifier: 09420012425041
• UDI-Public: (01)09420012425041(10)2100105037(11)161115
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: ICONNAN-HT
• Device Catalogue Number: ICONNAN-HT
• Device Lot Number: 2100105037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2016
• 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