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

Model Number ICONPBN-HT

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint icon cpap is currently in transit for evaluation.A follow-up report will be provided upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported that the power cord of an icon cpap humidifier had damaged primary insulation.There was no patient consequence.

Event Description

A healthcare facility in canada reported that the power cord of an icon cpap humidifier had damaged primary insulation.Upon evaluation of the device, it was actually discovered that the primary insulation was intact.There was no patient consequence.

Manufacturer Narrative

Ps309013 method: the complaint icon cpap was returned to fisher & paykel healthcare (f&p) in new zealand and was visually inspected and tested.Results: visual inspection revealed that the grommet sleeve of the power cord became was damaged at the unit end.The power cord was still attached to the icon unit and the inner insulation was intact with no copper conductor wires exposed.Conclusion: based on the investigation conducted, the power cord may have been subjected to an excessive force causing the reported damage.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.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 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: 8652737
• MDR Text Key: 146495478
• Report Number: 9611451-2019-00540
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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: 150410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1