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

Model Number IRC5PO2

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned for evaluation as of the date of this investigation.Rma was issued.If new information becomes available at a later date this complaint will be updated and/or a follow up be sent.

Event Description

Customer states the unit has no 02 light.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the pcb screw was missing.This would cause the pcb to pull away from the display so that the low o2 light would not be visible, which confirms the original complaint issue.

Event Description

Customer states the unit has no 02 light.

• 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: 5412485
• MDR Text Key: 37530434
• Report Number: 1031452-2016-00430
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• 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: 02/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2016
• 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