MAUDE Adverse Event Report: TELEFLEX HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONG; OXYGEN MASK - NONREBREATHING

Catalog Number 1059

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

The customer alleges that the new design star lumen tubing doesn't fit as tight/firmly as the prior smooth bore model.During use in a bariatric chamber when the mask was tugged the line came off.No patient injury.Had to stop therapy and reconnect.

Manufacturer Narrative

A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The product was assembled and inspected according to specifications.The sample was received, however, the evaluation was not complete at the time of this report.A follow-up report will be submitted upon completion of the investigation.

• Brand Name: HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONG
• Type of Device: OXYGEN MASK - NONREBREATHING
• Manufacturer (Section D): TELEFLEX; research triangle park NC
• Manufacturer Contact: katharine tarpley ; po box 12600; rtp, NC 27709 ; 9194334854
• MDR Report Key: 4172818
• MDR Text Key: 14881287
• Report Number: 3004365956-2014-00371
• Device Sequence Number: 1
• Product Code: KGB
• 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: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1059
• Device Lot Number: 02B1402779
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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