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

Catalog Number 382-10

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: ventilationqn# (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 Description

Rt is having issues on infant vent using servo i and servo u vent when using pressure control mode.Patient volumes decrease using the smart column in circuit 780-18kit.It was reported the ventilaor has a low volume alert if the patient volumes drop.The patient was on pressure settings when volume declined, and the staff responded timely before any desaturations.The intervention was to change the column to a 382-30, which the issue of low volumes to the patient resolved.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10782058
• MDR Text Key: 214556141
• Report Number: 3004365956-2020-00219
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382-10
• Device Lot Number: 74E2001428
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1