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

Model Number IRC5PO2

Device Problems Loss of Power (1475); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available for the patient a supplemental record will be filed.

Event Description

The dealer stated it shuts down with 1 red 5 green.The dealer stated he caught the scent of ozone and then he saw some smoke so he shut the unit off.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.Per the expanded evaluation report, the only failure observed was that of the compressor not powering on, which was likely caused by a defect on the circuit board, but the specific source could not be determined.Upon startup, the unit did give a continuous alarm, red warning light, and no output.The compressor was not powering on with the rest of the electronics.The compressor outflow line had been modified and its capacitor was not tie-wrapped in place.The capacitance was slightly below specification but was determined not to be the source of the issue, as the fault condition was not resolved even upon installation of another capacitor that was within specification.Both the 4-way valve and pe valve were properly connected and shifted as they should.Confirmation of the functional valves with a persistent alarm suggested that there was a defect in the circuit board; however, no obvious damage was found.No smoke was observed coming from the fully assembled concentrator or from any of the parts upon testing.

Event Description

The dealer stated it shuts down with 1 red 5 green.The dealer stated he caught the scent of ozone and then he saw some smoke so he shut the unit off.

• 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: 5390164
• MDR Text Key: 36992896
• Report Number: 1031452-2016-00321
• 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,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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