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

Catalog Number 5900

Device Problems Electrical /Electronic Property Problem (1198); Material Frayed (1262)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges that the unit power cord is frayed and exposing electrical power wires.The alleged issue was discovered prior to use.No patient injury/involvement reported.

Manufacturer Narrative

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; research triangle park NC
• Manufacturer (Section G): TELEFLEX; 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: 3813230
• MDR Text Key: 4401614
• Report Number: 1044475-2014-00103
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1