MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DUAL HEATED DUAL DRAIN; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913853
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "customer states the concha smart water did not fill.The flow tube was unclamped, and the bottle appeared to be punctured.No injury or intervention.The "low water" alarmed and column was changed".Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn #(b)(4).The customer returned one conchasmart column (product code 382-10).No other circuit components were returned.Upon receipt the unit was visually inspected for outward, visible signs of misuse/abuse/neglect.Nothing was noted in terms of physical damage.It was observed that the upper flow tube was returned clamped.The unit was prepared for a full functional bench test in an attempt to replicate the reported defect.A known good lab inventory concha neptune 425-00, a water reservoir bottle, the remaining components of an adult breathing circuit (880-36kit), airflow, and dual temperature probes were used with the returned column.The unit successfully navigated all pre-operational self-tests with the returned column and was functioning in real time.The settings were set to full rainout, invasive, at 37 degrees c.The circuit functioned without any interruption and was able to heat up to the set temperature of 37 degrees c.Water was observed to be flowing through the column in real time while the circuit was functioning.There was no "low water" alarm observed.After functional testing, adequate water supply was confirmed as there was water removed from the column.The complaint cannot be confirmed.Functional testing did not reveal any operational anomalies.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "customer states the concha smart water did not fill.The flow tube was unclamped, and the bottle appeared to be punctured.No injury or intervention.The "low water" alarmed and column was changed".Patient condition reported as "fine".

• Brand Name: HUDSON DUAL HEATED DUAL DRAIN
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12631546
• Report Number: 3004365956-2021-00284
• Device Sequence Number: 4344816
• Product Code: OGG
• UDI-Device Identifier: 14026704660619
• UDI-Public: 14026704660619
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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 Expiration Date: 01/19/2026
• Device Model Number: IPN913853
• Device Catalogue Number: 880-36KIT
• Device Lot Number: 74A2100774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown