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

Model Number	IPN913861
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "on march 39th, a 2 week old on ventilator, in prvc setting, was not getting volume due to column.The vent was reading delivered volumes, but due to the column, the patient lungs were not.The patient heart rate increased and became tachypneic in noticeable work of breathing.The patient received an emergency bronchoscopy, fluid bolus and almost arrested.When the therapist noticed they were using a smart column.When the column was changed, they were able to ventilate the infant to a stable condition.No death occurred.Patient condition today is stable".It was reported that device was replaced.
Event or Problem Description
It was reported "on march 39th, a 2 week old on ventilator, in prvc setting, was not getting volume due to column.The vent was reading delivered volumes, but due to the column, the patient lungs were not.The patient heart rate increased and became tachypneic in noticeable work of breathing.The patient received an emergency bronchoscopy, fluid bolus and almost arrested.When the therapist noticed they were using a smart column.When the column was changed, they were able to ventilate the infant to a stable condition.No death occurred.Patient condition today is stable".It was reported that device was replaced.
Additional Manufacturer Narrative
Qn# (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.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11740120
• Report Number: 3004365956-2021-00178
• Device Sequence Number: 4167581
• Product Code: BTT
• UDI-Device Identifier: 14026704660671
• UDI-Public: 14026704660671
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K760866
• 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,Followup
• Report Date (Section B): 04/07/2021

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: No Information
• Device Model Number: IPN913861
• Device Catalogue Number: 382-10
• Device Lot Number: 74E2001428
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR; VENTILATOR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention