MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Dealer alleges the irc5po2 concentrator has no power and no alarms due to the power switch.

• Brand Name: PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• 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: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4637303
• MDR Text Key: 5577945
• Report Number: 1031452-2015-12794
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5PO2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2015
• 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