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 Consequences Or Impact To Patient (2199)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges that the unit will not operate at all.The alleged issue occurred during preparation for pt use.Another device was obtained for pt use.

Manufacturer Narrative

The device sample was not returned for eval 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; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3833117
• MDR Text Key: 18366677
• Report Number: 1044475-2014-00071
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/07/2014

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: Other
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1