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

Model Number ICONAAA

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint icon cpap was recently received at fisher & paykel healthcare(f&p) regional office in (b)(4).We are in process to determine if f&p's product casued or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(4) reported that an icon cpap humidifier had a damaged power cord.There was no reported patient involvement.

Event Description

A distributor in japan reported that an icon cpap humidifier had a damaged power cord.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint icon cpap was returned to fisher & paykel healthcare in new zealand where it was visually inspected.Results: visual inspection of the complaint unit revealed that the power cord insulation and the neutral conductor insulation had broken under the grommet area.The grommet was still intact.The inner primary insulation cables and copperwires were exposed on the neutral conductor.Conclusion: when power cord is subjected to prolonged bending around the grommet area, the force would induce a failure on outer sheath to tear.Also repetitive bending of the power cord would have affected and caused the outer insulation to tear.During initial assembly of the icon cpaps, all power cords are visually inspected for damage.Once the assembly process is completed, all the devices are visually inspected again before release for distribution.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 (power cord) and the cases are flame retardant according to ul 60601-1 and as/nzs 3200.1.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.".

• 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: 8458381
• MDR Text Key: 140618055
• Report Number: 9611451-2019-00283
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ICONAAA
• Device Catalogue Number: ICONAAA
• Device Lot Number: 2100028408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1