MAUDE Adverse Event Report: TELEFELX HUDSON AQUAPAN 301 SW, 340 ML, JAPAN; BUBBLE HUMIDIFIER

Catalog Number 003-01J

Device Problem Pressure Problem (3012)

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

Event Date 07/14/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that air did not come out of the swan neck smoothly.

Manufacturer Narrative

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

• Brand Name: HUDSON AQUAPAN 301 SW, 340 ML, JAPAN
• Type of Device: BUBBLE HUMIDIFIER
• Manufacturer (Section D): TELEFELX; rtp NC
• Manufacturer (Section G): TELEFELX; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4109107
• MDR Text Key: 4836441
• Report Number: 1417411-2014-00062
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/21/2014

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: 003-01J
• Device Lot Number: 619137
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1