MAUDE Adverse Event Report: ROSCOE MEDICAL MINI COMPRESSOR NEBULIZER

Device Problems Break (1069); Thermal Decomposition of Device (1071); Failure to Power Up (1476); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

Pt brought nebulizer back to our home medical equipment division and the power cord was burned where it attaches to machine.No injury occurred, however, due to concern of potential fire, as well as history of issues with 4 other units resulted in our filling out this report.These are other serial numbers and concerns reported for the same device make and model due to pts bringing them back.Broken component within machine rattling.Procedure.Broken component within machine rattling.Would not power on.

• Brand Name: MINI COMPRESSOR NEBULIZER
• Type of Device: MINI COMPRESSOR NEBULIZER
• Manufacturer (Section D): ROSCOE MEDICAL; strongville OH
• MDR Report Key: 3750153
• MDR Text Key: 16802239
• Report Number: MW5035610
• Device Sequence Number: 3
• 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: 04/09/2014
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1