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 No Consequences Or Impact To Patient (2199)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

End user advised, unit stopped working.

• 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: 4324324
• MDR Text Key: 15912230
• Report Number: 1531186-2014-06176
• 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: 12/10/2014,11/20/2014

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?: No
• 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: 12/10/2014
• Distributor Facility Aware Date: 11/20/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 12/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other