MAUDE Adverse Event Report: TELEFLEX HUDSON, THERMAGARD NEBULIZER HEATER

Catalog Number 5705

Device Problems Insufficient Heating (1287); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

The event is reported as: the unit is not working.The unit will not heat.The unit was changed out.The pt condition is reported as fine.

Manufacturer Narrative

The device sample was not returned for eval at the time of this report.

• Brand Name: HUDSON, THERMAGARD NEBULIZER HEATER
• Type of Device: NEBULIZER HEATER
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; po box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3908711
• MDR Text Key: 15104178
• Report Number: 1044475-2014-00126
• 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: Other,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2014
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2014
• 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