MAUDE Adverse Event Report: TELEFLEX HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE; COMPRESSOR NEBULIZER SYSTEM

Catalog Number 5900

Device Problem Failure to Power Up (1476)

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

Event Date 01/14/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer (end-user) reports that the device was stored in a closet for several months after being purchased.When the customer was ready to use the device, it was noted that the unit would not power on.No report of a patient injury.

Manufacturer Narrative

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

• Brand Name: HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE
• Type of Device: COMPRESSOR NEBULIZER SYSTEM
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.; rtp NC 27709
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3753053
• MDR Text Key: 17954875
• Report Number: 1044475-2014-00016
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1