MAUDE Adverse Event Report: TELEFLEX HUDSON OPTI-NEB PRO COMPRESSOR Q/DISPOSABLE; NEBULIER COMPRESSOR

Catalog Number 5900

Device Problems Restricted Flow rate (1248); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the nurse alleges that her home care pt is experiencing extremely slow nebulization treatment from the device and that the device is running extremely loud.The pt condition is reported as fine.

Manufacturer Narrative

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

• Brand Name: HUDSON OPTI-NEB PRO COMPRESSOR Q/DISPOSABLE
• Type of Device: NEBULIER COMPRESSOR
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn, regulatory af ; p.o. box 12600; research triangle park, NC 27709 ; 9194334965
• MDR Report Key: 3837812
• MDR Text Key: 4412369
• Report Number: 1044475-2014-00112
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• 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?: Yes
• Date Manufacturer Received: 04/02/2014
• 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