MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO

Catalog Number 048-91

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

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the 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 complaint.A record assessment (fmea) was conducted and no update is required.Customer complaint cannot be confirmed based on the information provided.It is necessary to receive the device sample to perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish any corresponding corrective actions.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 "aquatherm (was) working when patient went to bed.Water was cold in the morning." alleged issue reported as occurred during use.There was no report of patient impact or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and the unit passed the tests.In additional, the unit was left on for a period of 2 hours and connected to a thermometer and its temperature was kept within specification (208 to 222 f), therefore the unit heats properly.Based on the investigation performed, the reported complaint could not be confirmed.All aquatherm heaters are 100% inspected during manufacturing; therefore, any defects would be detected prior to release from the manufacturing facility.

Event Description

Customer complaint alleges the "aquatherm (was) working when patient went to bed.Water was cold in the morning." alleged issue reported as occurred during use.There was no report of patient impact or consequence.

• Brand Name: HUDSON AQUATHERM HEATER 091
• 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: 7447814
• MDR Text Key: 106144258
• Report Number: 3003898360-2018-00313
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 04/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• 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