MAUDE Adverse Event Report: TELEFLEX 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 04/16/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges the device will no longer nebulize medication to the extent of efficacy of the treatment.The unit was changed out.No patient injury/harm.

Manufacturer Narrative

The unit was received loose in a box, 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 optineb.No cracks, dents.Some light scratches and dings associated with regular usage.The compressor was connected to a 110 volt ac power source and was turned on; the motor would not run.After further investigation it was determined that the buss fuse was blown creating an open circuit.The open circuit condition will not allow the electrical current to flow, rendering the unit disabled.Once current flow has been interrupted the motor will not operate.The complaint reads that the issue is low pressure output.In this scenario the motor will not energize at all.The complaint is confirmed in terms of the unit not performing as it should.Dhr file is not available for review in the us.The complaint is confirmed; however the root cause cannot be established as the conditions of operation are not known.Blown fuses can be the result of shorted electrical circuits, power surges, etc.Of which none of these are known.No corrective/preventative action assignments made.Conclusion code could not be found for the unknown root cause.

• Brand Name: HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE
• Type of Device: NEBULIZER COMPRESSOR
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.
• Manufacturer Contact: margie burton, rn, ra ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3896453
• MDR Text Key: 4651653
• Report Number: 1044475-2014-00129
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2014

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: Lay User/Patient
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1