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

Model Number ICONPBN-HT

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint icon cpap is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that an icon cpap humidifier had a broken power cord.Upon additional information received from the customer on 18 december 2019, it was reported that the power cord had exposed wires.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Follow up #2 d5 correction-health professional to lay user/patient.Method: the complaint icon cpap humidifier was received at fisher & paykel healthcare in new zealand for evaluation.The icon cpap power cord was visually inspected.Results: visual inspection of the complaint icon cpap power cord showed the primary insulation was exposed, however no copper wires were visible.Conclusion: there was no reportable fault found with the complaint device.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 healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that an icon cpap humidifier had a broken power cord.Upon additional information received from the customer on (b)(6) 2019, it was reported that the power cord had exposed wires.There was no reported patient involvement.

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that an icon cpap humidifier had a broken power cord.Upon additional information received from the customer on 18 december 2019, it was reported that the power cord had exposed wires.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).D5 correction- lay user/patient to health professional.Method: the complaint icon cpap humidifier was received at fisher & paykel healthcare in new zealand for evaluation.The icon cpap power cord was visually inspected.Results: visual inspection of the complaint icon cpap power cord showed the primary insulation was exposed, however no copper wires were visible.Conclusion: there was no reportable fault found with the complaint device.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.".

• 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
• MDR Report Key: 9584534
• MDR Text Key: 182348730
• Report Number: 9611451-2020-00052
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K094040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: ICONPBN-HT
• Device Catalogue Number: ICONPBN-HT
• Device Lot Number: 140306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 02/26/2020
• Supplement Dates FDA Received: 03/26/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1