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 Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

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 the sample is not available and 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 of similar complaints.

Event Description

The customer alleges that the unit is not heating up.No patient injury reported.

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 two of the functional tests, however, the current test was not able to be conducted as an open circuit was detected and the unit did not heat up.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be determined.All aquatherm heaters are 100% tested at the manufacturing facility; therefore, it is unlikely that this occurred during manufacturing.A defect of this type would have been detected during the final inspection test.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 is not heating up.No patient injury reported.

• 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: 5429993
• MDR Text Key: 37978115
• Report Number: 3003898360-2016-00125
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• 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: 02/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2014
• 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