MAUDE Adverse Event Report: RESPIRONICS INC ENVOY AER COMPRESSOR 230V AUS 9153632953; COMPRESSOR, AIR, PORTABLE

Model Number IRC1710

Device Problem Improper Flow or Infusion (2954)

Patient Problem Missed Dose (2561)

Event Type  Injury  

Event Description

It has been reported by the end user that the irc1710 aerosol compressor is not delivering the medication.

• Brand Name: ENVOY AER COMPRESSOR 230V AUS 9153632953
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 1010 murry ridge lane; murrysville PA 15668
• MDR Report Key: 4325828
• MDR Text Key: 15111676
• Report Number: 1531186-2014-06219
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/11/2014,10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC1710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2014
• Distributor Facility Aware Date: 10/27/2014
• Device Age: 21 MO
• Date Report to Manufacturer: 12/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1