MAUDE Adverse Event Report: TELEFLEX HUDSON THERMAGARD NEBULIZER HEATER

Catalog Number 5705

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the unit is overheating; the temperature cannot be controlled at the temperature knob.No patient injury.

Manufacturer Narrative

Per device history record review the unit did not present any problem or malfunction during the production process.The heater was tested per pegasus (pfg supplier) specifications.Pegasus indicates that the product was manufactured in accordance with gmp, and found to be in compliance with all applicable drawings, specifications and functional standards, as specified in pegasus production and quality procedures.The device sample was not returned for evaluation, therefore pegasus is unable to determine the cause of the alleged failure.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: NEBULIZER HEATER
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 4122189
• MDR Text Key: 4937472
• Report Number: 1044475-2014-00268
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1