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

Model Number	ICONPBN
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint icon cpap humidifier is currently en route to fisher & paykel healthcare for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(4) reported that an icon cpap humidifier had a broken power cord.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).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 outer sheath of the power cord had broken under the grommet area and the grommet was still intact.The inner insulation was exposed however no copper conductor wires were exposed.Conclusion: based on the investigation conducted, the power cord may have been subjected to prolonged bending 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.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 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.".
Event or Problem Description
A healthcare facility in canada reported that an icon cpap humidifier had a broken power cord.There was no patient involvement.

• 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
• MDR Report Key: 10519225
• Report Number: 9611451-2020-00764
• Device Sequence Number: 3033156
• Product Code: BZD
• UDI-Device Identifier: 09420012425034
• UDI-Public: (01)09420012425034(10)2100134391(11)170117
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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: ICONPBN
• Device Catalogue Number: ICONPBN
• Device Lot Number: 2100134391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1