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 Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product usage when the alleged event was detected is unknown.Device sample received by the manufacturer, but the investigation is incomplete at this time.Device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.

Event Description

The customer alleges that the device does not heat up.There is no report of patient injury.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the unit was severely damaged.Functional testing was also performed and the unit passed all tests.A current test could not be conducted due to an open circuit.Based on the investigation performed, the complaint of "unit will not heat" was confirmed.All aquatherm heaters are 100% tested at the manufacturing facility; therefore, any defects would be detected prior to release.Based on the functional testing results, and the damage on the heater, it was determined that the unit was overstressed during use.

Event Description

The customer alleges that the device does not heat up.There is no report of patient injury.

• 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: 5886823
• MDR Text Key: 52457413
• Report Number: 3003898360-2016-00778
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• 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: 08/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• 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