MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM III,ELECTRONIC HEATER; LARGE VOLUME NEBULIZER HEATER

Catalog Number 050-14

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2015

Event Type  malfunction  

Event Description

The customer alleges that the device would not heat.It is unknown when the alleged issue was detected.No report of a patient injury.

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.The device history record investigation did not show issues related to complaint.The device was manufacturer on 06/01/2010.A document assessment (fmea) was conducted and no changes required.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that a knob was missing on the unit, and there was corrosion on the control board.No other issues were found.Functional testing was performed and the unit failed the electrical current test.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 the issue found in the sample occurred during manufacturing.A defect of this type would be detected during the final inspection test.

Event Description

The customer alleges that the device would not heat.It is unknown when the alleged issue was detected.No report of a patient injury.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: LARGE VOLUME NEBULIZER HEATER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4869121
• MDR Text Key: 18719591
• Report Number: 3003898360-2015-00471
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 050-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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