MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMIDIFIER,DISPOSABLE; HUMIDIFIER, RESPIRATORY GAS, (

Model Number	IPN913994
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the patient's husband noticed that the flow rate ball of concentrator 02 was < 4l / min.He also observed he could not increase the flow.He removed the humidifier; the consequence was that the concentrator had a properly working flow.He removed the micro- diffuser and the flow was also normal.We observed that the diffuser is "hard" (limestone ) whereas the water used by the patient is low in limestone.The diffuser was only used for 15 days.The diffuser jar was clean".No patient injury or harm reported.Patient condition reported as "fine".
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.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were encountered.The complaint could not be confirmed as the device functioned as intended.No issues were encountered.
Event or Problem Description
It was reported that: "the patient's husband noticed that the flow rate ball of concentrator 02 was < 4l / min.He also observed he could not increase the flow.He removed the humidifier; the consequence was that the concentrator had a properly working flow.He removed the micro- diffuser and the flow was also normal.We observed that the diffuser is "hard" (limestone ) whereas the water used by the patient is low in limestone.The diffuser was only used for 15 days.The diffuser jar was clean".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON HUMIDIFIER,DISPOSABLE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• 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: 12800469
• Report Number: 3004365956-2021-00300
• Device Sequence Number: 14830760
• Product Code: BTT
• UDI-Device Identifier: 14026704657169
• UDI-Public: 14026704657169
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: Lay User/Patient
• Device Expiration Date: 07/09/2025
• Device Model Number: IPN913994
• Device Catalogue Number: 3230
• Device Lot Number: 74G2000926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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