MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ICON+ PREMO CPAP HUMIDIFIER; BZD

Model Number	ICONPBN
Medical Device Problem Codes	Device Issue (2379); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint icon+ premo cpap humidifier is en route to fisher & paykel healthcare in (b)(4) for investigation to determine if it had a malfunction, which could have caused or contributed to the reported incident.We are also in the process of obtaining further information from the healthcare facility regarding the reported incident.We will provide a follow up report once we have completed our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported that the icon+ premo cpap humidifier had condensation issues.It was also reported that the patient was alleging that the condensate went into her lungs.The incident occurred six weeks after the patient was set up on icon humidifier.No medical or surgical intervention was reported as a result of this incident.
Additional Manufacturer Narrative
(b)(4).Method: the complaint icon+ premo cpap humidifier was returned to f&p healthcare in new zealand for investigation.It was visually inspected and performance tested.Our analysis is accordingly based on the results of our investigation, and additional information we received from the healthcare facility.Results: the returned icon+ unit was inspected externally, and showed no signs of impact damage.When power was applied, the unit turned on and functioned normally.The internal fault log was checked, and no faults were recorded.The unit was tested by running it for two hours.The unit continued running at the end of this period, and no error codes were displayed.The returned icon+ was subsequently tested with a chamber filled with water, and compared to a known good icon+ unit.Both units were set with the same humidity and pressure settings under the same environmental conditions.Test result showed the amount of water consumed by both icon+ units was comparable.The complaint icon+ unit was also opened for further investigation, and no evidence of any fault was observed.Attempts were made to obtain more information from the patient regarding the reported incident; however, no significant information was received.The healthcare facility was not able to confirm if the patient had actually consulted her physician.The healthcare facility did not consult a physician either when they were notified by the patient about the water that allegedly went inside her lungs.The healthcare facility confirmed that no diagnosis and supporting investigations were undertaken when the reported incident occured.They are also not aware if the patient has any concurrent medical concerns.Conclusion: no evidence of any fault was observed during testing of the complaint icon+ unit that could cause the reported incident.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple set-up and environmental factors.The user and care manual that accompany the icon+ cpap humidifier state the following: "ensure the device is stored and operated on a surface, level or below head height, to prevent water entering the tube and the device enclosure." "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 perrysburg, ohio reported that the icon+ premo cpap humidifier had condensation issues.It was also reported that the patient was alleging that the condensate went into her lungs.The incident occurred six weeks after the patient was set up on icon humidifier.No medical or surgical intervention was reported as a result of this incident.

• Brand Name: ICON+ PREMO CPAP HUMIDIFIER
• Common Device Name: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• MDR Report Key: 7308269
• Report Number: 9611451-2018-00154
• Device Sequence Number: 11133812
• Product Code: BZD
• UDI-Device Identifier: 09420012425034
• UDI-Public: (01)09420012425034(10)2100283811(11)170807
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K094040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICONPBN
• Device Catalogue Number: ICONPBN
• Device Lot Number: 2100283811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other