MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM III,ELECTRONIC HEATER; BREATHING SYSTEM HEATER

Catalog Number 050-14

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

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.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the sample is not available it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to be monitor and trend on similar complaints.

Event Description

The customer alleges that the device will not work.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The complaint sample was received and there were no visual defects detected during the visual inspection.The safety analyzer test was performed during functional testing and the device passed.However, the device failed the electrical test as the thermal-fuse component was detected open.The reported complaint was confirmed through functional inspection however, the root cause is unknown.Although the reported defect was confirmed, it is unlikely the issue occurred during manufacturing as all aquatherms are 100% tested during manufacturing.Therefore this defect would have been detected during the final inspection of the device.A conclusion code could not be chosen as the complaint was confirmed however, a root cause could not be established.Teleflex will continue to monitor and trend relating complaints.

Event Description

The customer alleges that the device will not work.The patient's condition is reported as fine.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: BREATHING SYSTEM HEATER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5675878
• MDR Text Key: 45785055
• Report Number: 3003898360-2016-00563
• Device Sequence Number: 1
• Product Code: BZE
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1