MAUDE Adverse Event Report: TELEFLEX HUDSON THERMAGARD NEBULIZER HEATER; LARGE VOLUME NEBULIZER HEATER

Catalog Number 5705

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the unit is overheating during patient use.

Manufacturer Narrative

The investigation was not complete at the time of this report.A follow-up report will be submitted upon completion of the investigation.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: LARGE VOLUME NEBULIZER HEATER
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; p.o. box 12600; rtp, NC 27709 ; 9194334854
• MDR Report Key: 4219032
• MDR Text Key: 4998554
• Report Number: 1044475-2014-00206
• Device Sequence Number: 1
• Product Code: BTT
• 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: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1