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

Catalog Number 050-14

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

Patient Problem No Patient Involvement (2645)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history record investigation did not show issues related to complaint.A record assessment (fmea) was conducted and no update is required.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint alleges the device is no longer heating.Usage of the device at the time the alleged malfunction occurred is unknown.There was no report of patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.The components were assembled correctly.Functional testing was performed and the unit passed the testing.In addition, the unit was tested (heating) placing the potentiometer on the three positions: minimum, medium and maximum.It was observed that the unit does not heat in the three positions.The sample was opened (housing) and during the evaluation it was detected that the unit contains water residue in the sponge of the pcb card.It is not known why the unit contains water inside.Based on the investigation performed, the complaint was confirmed.Although the complaint was confirmed, a root cause for the issue could not be determined.It is not known why the sample contains water on the inside.This condition could contributed to the reported failure.All aquatherm heaters are 100% tested by manufacturing; therefore, it is unlikely that the issue found in the sample occurred during manufacturing.This defect would have been detected during the final inspection test.*a conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges the device is no longer heating.Usage of the device at the time the alleged malfunction occurred is unknown.There was no report of patient involvement.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7525940
• MDR Text Key: 108642527
• Report Number: 3003898360-2018-00362
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: 05/07/2018
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1