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 Type  malfunction  

Event Description

End user's mother alleges the unit is not dispensing.No vapor.There is power to unit.No further information provided.

• 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: 4461808
• MDR Text Key: 21929682
• Report Number: 1531186-2015-00624
• Device Sequence Number: 1
• Product Code: CAW
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/27/2015,01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• 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: 01/27/2015
• Distributor Facility Aware Date: 01/22/2015
• Device Age: 5 YR
• Date Report to Manufacturer: 01/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other