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

Catalog Number 5900

Device Problems Defective Device (2588); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the unit is broken and is too loud.The pt's condition is reported as fine.

Manufacturer Narrative

The unit was received loose in a poly zip-lock bag, unprotected.No outward visual signs of abuse/misuse other than normal signs of wear and tear over time.No discoloration or signs of contamination present on the body on the opti-neb.No cracks, dents.Some light scratches and dings associated with a regular usage.The compressor was connected to a 110 volt ac power source and was turned on; the unit ran without incident.An oxygen tube was connected to the compressor air exit port and the other end was connected to a hudson up-draft ii, opti-neb nebulizer that had been filled with tap water.The compressor was turned on: the air pressure coming from the opti-neb was sufficient enough to create a thick, plume of mist.The unit was loud which is an indication of usage, but still operating.No corrective action required as complaint cannot be confirmed.Root cause cannot be established.Unit operates as intended.

• 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.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 4099032
• MDR Text Key: 4701990
• Report Number: 1044475-2014-00244
• 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,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/07/2014

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2014
• Initial Date FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1