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

Catalog Number 050-14

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint was not returned to the manufacturer at the time of this initial report.A verification of failure mode reported in the current manufacturing process was conducted.Eleven devices were taken from the current production p/n 050-14 aquatherm iii,electronic heater lot # 73g180001n.Samples were functionally inspected, and during the test issue reported "dial does not turn prior to use" was not observed in the current manufacturing process.Trending history review shows for period (b)(6) 2017-(b)(6) 2018 one complaint received with similar issue.A record assessment (fmea) was conducted and no update is required.Customer complaint cannot be confirmed at this time.If the device sample becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the dial does not turn and cannot control the heat." alleged issue reported as detected during pre-testing prior to a patient use.

Manufacturer Narrative

(b)(4).One (1) unit of catalog number: 050-14 (aquatherm iii , electronic heater), serial number: (b)(4), was received for analysis.It was found that the knob turns freely and stops at the minimum and maximum value.Functional testing was performed and the unit passed all tests conducted.The unit was tested (heating) placing the potentiometer on the three positions: minimum, medium and maximum.As result, it was observed that the unit does not heat in the three positions; temperature was maintained in 22.8 c.Then the sample was opened (housing) and during the evaluation it was detected that the pcb was damaged.It is not known how the damage occurred.A device history record review was performed on the lot number of the sample received and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint of "dial does not turn prior to use" could not be confirmed.It was found that the knob turns freely and stopes at the minimum and maximum values.All products are 100% tested at the manufacturing facility; therefore, any defects would be detected prior to release.

Event Description

Customer complaint alleges "the dial does not turn and cannot control the heat." alleged issue reported as detected during pre-testing prior to a patient use.

• 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: 7670622
• MDR Text Key: 113508819
• Report Number: 3003898360-2018-00555
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1