MAUDE Adverse Event Report: ROSCOE MEDICAL MINI COMPRESSOR NEBULIZER

Model Number NEB-ROS

Device Problems Thermal Decomposition of Device (1071); Sparking (2595); Temperature Problem (3022); Noise, Audible (3273)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

Reporting multiple issues with same nebulizer we reported earlier this year ((b)(6) 2014).Electrical cord is sparking, some units appear to have a "burned" area and some units sound as if there are broken pieces inside the unit.Most issues are heat related.We have stopped issuing/purchasing this unit to issue in our home medical equipment area but patient are still bringing defective units back.Also see report mw5035610.

• Brand Name: MINI COMPRESSOR NEBULIZER
• Type of Device: MINI COMPRESSOR NEBULIZER
• Manufacturer (Section D): ROSCOE MEDICAL; strongsville OH *
• MDR Report Key: 4377682
• MDR Text Key: 16089249
• Report Number: MW5039854
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NEB-ROS
• Device Catalogue Number: NEB-ROS
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1