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); Noise, Audible (3273)

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

Event Date 08/26/2014

Event Type  malfunction  

Event Description

The customer alleges that the medication is not being infused properly.The treatment is taking too long and the mist is very light.The motor is running louder.No report of patient injury.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.Serial number of the device: (b)(4).

• 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 ; po box 12600; research triangle park, NC 27709 ; 9194334965
• MDR Report Key: 4240085
• MDR Text Key: 5015289
• Report Number: 1044475-2014-00301
• 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: Other
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• 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: 10/23/2014
• 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
• Patient Sequence Number: 1