MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM HEATER 091; BREATHING SYSTEM HEATER

Catalog Number 048-91

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per the device history record, the device was manufactured on 03/30/2015.The device history record did not show issues related to the complaint.A document assessment (fmea) was conducted and no changes were required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on similar complaints.

Event Description

The customer alleges that the unit is only warming the gas to 22-24 degrees c.No patient injury/harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and cracks were observed on the unit.No other issues were observed.An electrical evaluation was performed and it was detected that the thermo-fuse was damaged and the unit was overheating.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the defect could not be established.All aquatherm heater products are 100% tested at the manufacturing facility; 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 chosen as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer alleges that the unit is only warming the gas to 22-24 degrees c.No patient injury/harm reported.

• Brand Name: HUDSON AQUATHERM HEATER 091
• Type of Device: BREATHING SYSTEM HEATER
• 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: 5366397
• MDR Text Key: 35994223
• Report Number: 3003898360-2016-00030
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• 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: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• 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: Unknown
• Patient Sequence Number: 1