MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL); 868.5440

Model Number IRC10LXO2

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the device is alarming and the intake filter looks black.

• Brand Name: PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
• Type of Device: 868.5440
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4009688
• MDR Text Key: 4952432
• Report Number: 1031452-2014-05958
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC10LXO2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other