MAUDE Adverse Event Report: HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Model Number	IPN913861
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A visual inspection of the product involved in the complaint was performed on a picture received by the customer of product code 382-10 (universal concha column).The customer description states "this is a hole in the column."the rts noticed a puddle of water underneath the neptune heater.The white part in the center of the circle is the water wicking paper.Additionally, note the burn marks on the column from water leakage out of the hole and down on to the floor".During the visual inspection to received picture the hole in the column reported by customer is not clear visible however marks are present in the received picture that appears to be burn marks as it is describe on this customer complaint.Sample needs to be evaluated to perform a proper investigation and determine the root cause.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.
Event or Problem Description
It was reported "the rts noticed a puddle of water underneath the neptune heater.The white part in the center of the circle is the water wicking paper.Additionally, note the burn marks on the column from water leakage out of the hole and down on to the floor".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11748113
• Report Number: 3004365956-2021-00169
• Device Sequence Number: 19832972
• Product Code: BTT
• UDI-Device Identifier: 14026704660671
• UDI-Public: 14026704660671
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K141940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN913861
• Device Catalogue Number: 382-10
• Device Lot Number: 74H20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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