ICON SERIES CPAP ICONAAN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-13 for ICON SERIES CPAP ICONAAN manufactured by Fisher & Paykel Healthcare Ltd.

Event Text Entries

[182581435] (b)(4). Method: the complaint icon cpap was not returned to fisher & paykel healthcare (f&p) for evaluation. Our investigation is thus based on the information provided by the customer. Results: customer reported that the icon cpap has a damaged power cord. Conclusion: based on the information we are unable to determine what caused the reported failure. 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 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. "
Patient Sequence No: 1, Text Type: N, H10


[182581436] A patient reported that an icon cpap humidifier had a damaged power cord. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00031
MDR Report Key9584532
Report SourceCONSUMER
Date Received2020-01-13
Date of Report2020-01-03
Date Mfgr Received2020-01-03
Device Manufacturer Date2015-07-28
Date Added to Maude2020-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DR., SUITE 100
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494534000
Manufacturer G1FISHER & PAYKEL HEALTHCARE LTD
Manufacturer Street15 MAURICE PAYKEL PLACE EAST TAMAKI
Manufacturer CityAUCKLAND, 2013
Manufacturer CountryNZ
Manufacturer Postal Code2013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICON SERIES CPAP
Generic NameBZD
Product CodeBZD
Date Received2020-01-13
Model NumberICONAAN
Catalog NumberICONAAN
Lot Number150728
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFISHER & PAYKEL HEALTHCARE LTD
Manufacturer Address15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

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