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

Catalog Number 050-12E

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record investigation did not show issues related to this complaint.A record 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.Customer complaint cannot be confirmed based on the information received.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

Customer complaint alleges that the doctor in the "icu dept, (b)(6) hospital, found the nebulizer heater can't be heated during clinic use".It was reported there was no medical intervention necessary.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also conducted and the unit passed the tests.It heated up on minimum (50.8 c), medium (86.7 c), and maximum (126.9 c) temperature settings during the testing and no issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges that the doctor in the "icu dept, (b)(6), found the nebulizer heater can't be heated during clinic use".It was reported there was no medical intervention necessary.Patient condition reported as "fine".

• Brand Name: HUDSON AQUATHERM III,UNITED KINGDOM
• 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: 6597843
• MDR Text Key: 76311917
• Report Number: 3003898360-2017-00670
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050-12E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2013
• 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