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

Catalog Number 050-14

Device Problems Insufficient Heating (1287); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The usage of the device in the reported event is unknown.A visual, functional, and dimensional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.Device history record investigation did not show issues related to 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 due the device sample not being returned.If the alleged device sample is received at a later date, this complaint will be updated accordingly.

Event Description

The customer alleges that the device's threads seemed stripped and the unit would not heat up.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the upper and lower housing were damaged.Functional testing was also performed and the unit passed the tests.The unit heated up on minimum, medium, and maximum temperature settings.Based on the investigation performed, the reported complaint could not be confirmed.The unit passed all functional testing.In addition, all units are 100% tested at the manufacturing facility; therefore, a defect of this type would be detected prior to release.

Event Description

The customer alleges that the device's threads seemed stripped and the unit would not heat up.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5924845
• MDR Text Key: 53818687
• Report Number: 3003898360-2016-00845
• 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: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• 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: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2013
• 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