MAUDE Adverse Event Report: TELEFLEX HUDSON CORRUGATED COMFORT FLO REMOTE TEMP PORT; CANNULA HUMIDIFCATION SYSTEM

Catalog Number 2416

Device Problems Disconnection (1171); Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the temperature probe did not fit properly into the circuit probe port.As a result, the probe is loose and disconnects from the circuit.The alleged issue was detected at the time of set-up.

Manufacturer Narrative

The exact cause of alleged defective devices is unk.

• Brand Name: HUDSON CORRUGATED COMFORT FLO REMOTE TEMP PORT
• Type of Device: CANNULA HUMIDIFCATION SYSTEM
• Manufacturer (Section D): TELEFLEX; rtp NC
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4109108
• MDR Text Key: 4700047
• Report Number: 3004365956-2014-00351
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2416
• Device Lot Number: 74D140256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1