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

Catalog Number 5900

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges the unit is not working; spitting air and making a loud noise.No patient harm or trauma as the unit was changed out for another one.

Manufacturer Narrative

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

• Brand Name: HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOABEL NE
• Type of Device: NEBULIZER COMPRESSOR
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn ; po box 12600; research triangle park, NC 27709 ; 9194334965
• MDR Report Key: 3938091
• MDR Text Key: 4573431
• Report Number: 1044475-2014-00055
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/20/2014

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
• Device Lot Number: 011226
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1