MAUDE Adverse Event Report: TELEFLEX HUDSON VENTILATOR TUBING SET, LONG LENGTH; BREATHING CIRCUIT

Catalog Number 1607

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that there is a sporadic disconnection with the circuit and the puritan bennett filter.The alleged issue was detected during pre-testing.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• Brand Name: HUDSON VENTILATOR TUBING SET, LONG LENGTH
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burtin, rn ; po box 12600; durhame, NC 27709 ; 9194334965
• MDR Report Key: 3955713
• MDR Text Key: 4560138
• Report Number: 3004365956-2014-00226
• Device Sequence Number: 1
• Product Code: CAG
• 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: 05/21/2014

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: Health Professional
• Device Catalogue Number: 1607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PURITAN BENNETT VENTILATOR; PURITAN BENNETT FILTER