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

Catalog Number 050-12J

Device Problem Failure to Deliver (2338)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/25/2015

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.Per dhr (device history record) the product aquatherm iii , (b)(4), serial # (b)(4) was manufactured on 01/05/2015.Dhr investigation did not show issues related to complaint.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 product 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 monitor and trend on similar complaints.

Event Description

The customer alleges that the heater did not nebulizer properly.The heater couldn't provide aerosol.A new unit was used without issue.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and the unit passed all tests.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

The customer alleges that the heater did not nebulizer properly.The heater couldn't provide aerosol.A new unit was used without issue.

• Brand Name: HUDSON AQUATHERM III,JAPANESE
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5214085
• MDR Text Key: 30879161
• Report Number: 3003898360-2015-00814
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-12J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1