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 Consequences Or Impact To Patient (2199)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation the time of this report.

Event Description

The customer alleges that the unit is no longer heating.No patient injury/harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the heater was received without accessories.The unit is approx.618 days of age and out of warranty.Upon evaluation of unit, it was found that the heating element was damaged, and no longer produced heat.Based on the investigation performed, the reported complaint was confirmed.The heater will be repaired and returned to the customer.

Event Description

The customer alleges that the unit is no longer heating.No patient injury/harm reported.

• 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; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5340053
• MDR Text Key: 34918622
• Report Number: 1044475-2016-00001
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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: 18989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• 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: Unknown
• Patient Sequence Number: 1