MAUDE Adverse Event Report: TELEFLEX HUDSON, NEBULIZER, LARGE VOLUME, INTL; LARGE VOLUME NEBULIZER

Catalog Number 41770

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339)

Patient Problem Respiratory Failure (2484)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

The event is reported as: the nebulizer does not mist and there is water collecting in the tubing.The patient had a respiratory arrest.It is reported that the patient survived the event.

Manufacturer Narrative

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

• Brand Name: HUDSON, NEBULIZER, LARGE VOLUME, INTL
• Type of Device: LARGE VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3824749
• MDR Text Key: 15366646
• Report Number: 3004365956-2014-00096
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41770
• Device Lot Number: 02C130263
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1