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

Catalog Number 5900

Device Problems Decrease in Pressure (1490); Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The customer (end-user) alleges that the compressor would not output sufficient flow.The alleged defect occurred during pre-testing.No patient injury reported.

Manufacturer Narrative

(b)(4).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: NEBULIZER COMPRESSOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4523902
• MDR Text Key: 5405248
• Report Number: 1044475-2015-00093
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• 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: 01/26/2015
• 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: Unknown
• Patient Sequence Number: 1