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

Catalog Number 048-91

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2017

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 received by the manufacturer 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 update is required.Customer complaint cannot be confirmed.It is necessary to receive the physical sample to perform a proper investigation to confirm the alleged defect, determine a root cause and any corresponding corrective actions.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges the device "has quit working".Usage of the device at the time of the alleged malfunction is unknown.There is no report of 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7007358
• MDR Text Key: 92461632
• Report Number: 3003898360-2017-01198
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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?: Yes
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• 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