MAUDE Adverse Event Report: RESPIRONICS INC PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL); 868.5440

Model Number IRC1730

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2014

Event Type  No Answer Provided  

Event Description

It was reported that irc1730 concentrator does not turn on or off at times.

• Brand Name: PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
• Type of Device: 868.5440
• Manufacturer (Section D): RESPIRONICS INC; 1010 murry ridge lane; murrysville PA 15668
• MDR Report Key: 3971391
• MDR Text Key: 4636040
• Report Number: 1531186-2014-02911
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/30/2014,06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC1730
• 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: 07/30/2014
• Distributor Facility Aware Date: 06/26/2014
• Device Age: 17 MO
• Date Report to Manufacturer: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other