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); Gas Output Problem (1266)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

Event Description

The dealer states the unit has low o2 at 5 lpm, was well below 85% and not alarming.

Manufacturer Narrative

Unit repaired by independent repair center.Irs received 10/2/15.Reason for repair is low o2 or yellow light.The key failure is a leaking pilot valve.The verification test 1 o2 purity was 87%.The underlying cause of the lower than expected o2 purity level documented in the irs is a stuck/not shifting pilot valve.Note: the unit's audible alarm is activated when the purity falls below 73%.Verification testing results provided on the irs indicate the o2 purity was at 87%.The unit audible alarm would not be triggered as they are above 73%.This is not a malfunction of the audible alarm system.

Event Description

The dealer states the unit has low o2 at 5 lpm, was well below 85% and not alarming.Independent repair center irs received 10/2/15.Reason for repair is low o2 or yellow light.The key failure is a leaking pilot valve.The verification test 1 o2 purity was 87%.The underlying cause of the lower than expected o2 purity level documented in the irs is a stuck/not shifting pilot valve.Note: the unit's audible alarm is activated when the purity falls below 73%.Verification testing results provided on the irs indicate the o2 purity was at 87%.The unit audible alarm would not be triggered as they are above 73%.This is not a malfunction of the audible alarm system.

• 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: 5063544
• MDR Text Key: 25911599
• Report Number: 1031452-2015-15885
• 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,other
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• 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: 10/02/2015
• 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