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 Patient Involvement (2645)

Event Date 03/07/2018

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.Verification of failure mode reported in the current manufacturing process was conducted as follows: 13 devices were taken from the current production and functionally inspected.During testing the issue reported was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number was not provided.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 physical sample to perform a proper investigation to confirm the alleged defect, and determine a root cause.Root cause is unknown.Corrective actions cannot be established.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges "unit stopped heating." alleged issue reported as detected prior to use.It was reported there was no 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 performed; however, a current test could not be performed due to an open circuit.It is possible that the open circuit was due to overheating of the unit.Based on the investigation performed, the reported complaint was confirmed.All aquatherm heaters are 100% inspected during manufact uring; therefore, a defect of this type would be detected prior to release from the manufacturing facility.It was determined that operational context caused or contributed to the reported defect.

Event Description

Customer complaint alleges "unit stopped heating." alleged issue reported as detected prior to use.It was reported there was no patient involvement.

• 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: 7377149
• MDR Text Key: 103684835
• Report Number: 3003898360-2018-00198
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 048-91
• Device Lot Number: SN:UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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