MAUDE Adverse Event Report: TELEFLEX HUDSON THERMAGARD NEBULIZER HEATER

Catalog Number 5705

Device Problem Insufficient Heating (1287)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the unit stopped heating while in use on a home patient.There was no harm encountered as a result of the alleged issue.

Manufacturer Narrative

The investigation was not complete at the time of this report.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: NEBULIZER HEATER
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck drive
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3824122
• MDR Text Key: 19802670
• Report Number: 1044475-2014-00028
• Device Sequence Number: 1
• Product Code: CAF
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1