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

Model Number IPN913994

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2021

Event Type  malfunction  

Event 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".

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.

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 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
• Type of Device: 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
• MDR Text Key: 284291947
• Report Number: 3004365956-2021-00300
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 14026704657169
• UDI-Public: 14026704657169
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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