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 Patient Involvement (2645)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history record review of the device involved in this complaint did not show any problems that could be related to the issue in this complaint.The estimated age of the device is 588 days.The device involved in this complaint has not been returned for evaluation at the time of this report.In order to perform a complete evaluation, it necessary to have the physical device sample.Therefore, the complaint cannot be confirmed.If the device sample is returned at a later date, this complaint will be updated.

Event Description

Customer complaint alleges "unit is not heating".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The unit was received without accessories.An evaluation was performed and it was found that the power switch lights up but the unit did not generate heat.The complaint of heater not working was confirmed.The heater presents a random thermal-fuse failure.The unit will be repaired and returned.

Event Description

Customer complaint alleges "unit is not heating".

• 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: 6193156
• MDR Text Key: 62963410
• Report Number: 3011137372-2016-00351
• 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: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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: SN 19844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• 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