MAUDE Adverse Event Report: TELEFLEX MEDICAL 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 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not returned at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted and no changes required.It is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.Customer complaint cannot be confirmed based on the information received.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

Customer complaint alleges "the heater no longer heats".Alleged malfunction reported as detected prior to use.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.Functional testing was also performed and the unit passed the tests conducted.The unit heated up on minimum, medium, and maximum temperature settings.Based on the investigation performed, the reported complaint could not be confirmed.The unit passed all functional testing.No issues were found with the returned device.

Event Description

Customer complaint alleges "the heater no longer heats".Alleged malfunction reported as detected prior to use.No report of patient involvement.

• Brand Name: AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• 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: 6689893
• MDR Text Key: 79177703
• Report Number: 3003898360-2017-00767
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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: SN:606090072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1