MAUDE Adverse Event Report: TELEFLEX HUDSON MASK, NON-REBREATH W/SAFTEY VENT, ELONGAT; OXYGEN MASK

Catalog Number 1059

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2013

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the bag attached to mask does not stay inflated.

Manufacturer Narrative

It is unknown if the device was in use on a patient.A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The dhr (device history record) review showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.The customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If defective sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON MASK, NON-REBREATH W/SAFTEY VENT, ELONGAT
• Type of Device: OXYGEN MASK
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3929944
• MDR Text Key: 4604722
• Report Number: 3004365956-2014-00114
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1059
• Device Lot Number: 02E1300892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1