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 12/01/2014

Event Type  malfunction  

Event Description

The customer alleges that the unit does not generate enough air pressure to nebulize medication.No pt injury reported.

Manufacturer Narrative

(b)(4).The device sample was received for eval, however, the investigation is incomplete 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: 4451375
• MDR Text Key: 5383112
• Report Number: 1044475-2015-00006
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5900
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1