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

Model Number IRC5PO2

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

A returned was issued and the product is awaiting receipt and/or evaluation.A follow up will be filed if/when any additional information is provided.

Event Description

Dealer advised, not putting out enough oxygen with no yellow 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 unit was leaking at the sieve beds and 4-way valve causing low o2, which confirmed the original complaint issue.However, there was no indication of a malfunction of the lights to illuminate.

Event Description

Dealer advised not putting out enough oxygen with no yellow 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: 5177538
• MDR Text Key: 29877094
• Report Number: 1031452-2015-16440
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• 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: 11/11/2015

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: IRC5PO2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 10/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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