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

Catalog Number 5705

Device Problem Device Stops Intermittently (1599)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/30/2015

Event Type  malfunction  

Event Description

The customer alleges that the device works intermittently.No report of a patient injury.

Manufacturer Narrative

(b)(4).Product usage when the alleged defect was encountered is unknown.The device sample was returned, but the investigation is incomplete at the time of this report.A device history was conducted and no issues were reported.The product was manufactured in accordance with good manufacturing practices and found to be incompliance with specifications.The estimated age of the device is approximately 462 days.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the heater was received with adapter ring, and the control knob is missing in the unit.The power switch lights up and the unit generates heat.The unit is approx 462 days of age.Based on the investigation performed, it was found that there was a damaged potentiometer stem due to impact.The unit is out of warranty.The unit can be repaired and returned to customer.

Event Description

The customer alleges that the device works intermittently.No report of a patient injury.

• Brand Name: HUDSON THERMAGARD NEBULIZER HEATER
• Type of Device: LARGE VOLUME NEBULIZER 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: 4934999
• MDR Text Key: 16850346
• Report Number: 1044475-2015-00256
• 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: Other,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• 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