MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER

Catalog Number 5705

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

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

Event Date 08/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned to the manufacturer, however, the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the investigation.

Event Description

Customer complaint alleges that the device is not warming.Alleged defect reported as detected prior to patient use/during functional testing.No report of patient harm.

Manufacturer Narrative

(b)(4).The unit was received and sent to the manufacturer (pegasus) for investigation.The manufacturer's investigation results are as follows: upon receipt of unit the claim was confirmed.The power switch did illuminate when turned on, but did not generate heat.Evaluation revealed that heater's thermal-fuse was at fault.The component was inspected and did not present any visible defect, and dhr shows that the heater was operable and within specifications at the time of release.This is a random component failure, which is not often seen in this units, especially at this age (138 days approximately).The thermal-fuse replaced and the heater was retested as per procedure and found to meet specifications.The unit is to be returned to customer as a warranty repair.

Event Description

Customer complaint alleges that the device is not warming.Alleged defect reported as detected prior to patient use/during functional testing.No report of patient harm.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: BREATHING SYSTEM HEATER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6834191
• MDR Text Key: 84128582
• Report Number: 3011137372-2017-00272
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5705
• Device Lot Number: 21640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• 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