MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON SMART CONCHA NO STERILE; RESPIRATORY GAS HUMIDIFIER

Catalog Number IP-5041NS

Device Problem Overfill (2404)

Patient Problems Asthma (1726); Respiratory Distress (2045); No Code Available (3191)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is uncertain if the user facility will release the device for investigation.Two photos for analysis, observed a comfort flo humidification system and a smart concha no sterile ip-5041ns.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

Patient was on 12 liters of high flow nasal cannula, when it was reported the system lavaged him during the therapy.Patient was bagged and placed on bipap and heliox.He was later intubated.At the time of this report, the patient was off the ventilator and on the floor, close to discharge.

• Brand Name: HUDSON SMART CONCHA NO STERILE
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 9172360
• MDR Text Key: 161715180
• Report Number: 3004365956-2019-00262
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/08/2023
• Device Catalogue Number: IP-5041NS
• Device Lot Number: 74H1800892
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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
• Treatment: NONE REPORTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 20 MO