MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM

Catalog Number 425-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that a burnt expiratory limb is the result of a malfunction of the neptune.No patient injury reported.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HEATED HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4121008
• MDR Text Key: 18540599
• Report Number: 3003898360-2014-00509
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1