MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM HEATER 091; BREATHING SYSTEM HEATER

Catalog Number 048-91

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

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

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) product usage when the alleged issue was detected is unknown.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.The sample was returned to the manufacturer, but the investigation is incomplete at the time of this report.

Event Description

The customer alleges that the unit will no longer heat when plugged in.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and the unit passed the tests; however, the current test was not able to be conducted as the thermal cutoff was detected open and the unit did not heat up.It is possible that this damage was due to overheating of the unit.Based on the investigation performed, the reported complaint of "unit will not heat" was confirmed.Although the product showed the defect, a corrective action could not be established due to the fact that all aquatherm heaters are 100% tested at the manufacturing facility; therefore, a defect of this type would be detected prior to release.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer alleges that the unit will no longer heat when plugged in.

• Brand Name: HUDSON AQUATHERM HEATER 091
• 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: 5573455
• MDR Text Key: 42525999
• Report Number: 3003898360-2016-00327
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 048-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• 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