MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMIDIFIER,DISPOSABLE,6 PSI; RESPIRATORY GAS HUMIDIFIER

Catalog Number 3260

Device Problems Restricted Flow rate (1248); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo for review.The device history record review shows that the product was assembled and inspected according to our specifications.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither being manufactured at the time.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

The customer alleges that the device is not working properly and is not providing enough oxygen to the patient.Another device was used without issue.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation, along with unopened representative samples.A visual exam was performed on all returned samp les and no defects were observed.Functional testing was also performed on all samples and no issues were observed.They were all found to be within specification.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the actual complaint sample or the representative samples that were returned.

Event Description

The customer alleges that the device is not working properly and is not providing enough oxygen to the patient.Another device was used without issue.

• Brand Name: HUDSON HUMIDIFIER,DISPOSABLE,6 PSI
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park 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 ; 9194334854
• MDR Report Key: 5564495
• MDR Text Key: 42269024
• Report Number: 3004365956-2016-00188
• 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,Followup
• Report Date: 03/30/2016

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
• Device Operator: No Information
• Device Catalogue Number: 3260
• Device Lot Number: 74J1501979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2015
• 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