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

Model Number IRC5PO2V CONCENTRATOR

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(6) 2014 - no injury alleged.Malfunction alleged.Per provider the manifold valve is bad and unit is shutting down.

• 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: 3950667
• MDR Text Key: 4645118
• Report Number: 1031452-2014-04092
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/21/2014,06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5PO2V CONCENTRATOR
• 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: 07/21/2014
• Distributor Facility Aware Date: 06/16/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 07/21/2014
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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