MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER

Catalog Number 5705

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that the device is not working during patient use.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.It was received with the gray adapter ring.It was found that the power switch illuminates when turned on, and the unit generates heat.The heater was inspected for physical damage, electrical safety, and temperature performance with an open chamber.It was found to meet specifications.The unit was closed up and re-tested for electrical safety and temperature performance and no anomalies were observed.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The heater met specifications.

Event Description

The customer alleges that the device is not working during patient use.The patient's condition is reported as fine.

• 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: 5267962
• MDR Text Key: 32949884
• Report Number: 1044475-2015-00397
• 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: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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 19776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• 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