MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 OXYGEN CONCENTRATOR 9153646962; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5P

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

It was reported that there was an alternative source of oxygen available, but the consumer chose not to utilize the alternative source of oxygen.User¿s manual review (1143482 rev.F, page 5) caution - invacare recommends an alternate source of supplemental oxygen in the event of a power outage, alarm condition or mechanical failure.Consult your physician or equipment provider for the type of reserve system required.This equipment is to be used as an oxygen supplement and is not considered life supporting or life sustaining.Should additional information become available a supplemental record will be filed.

Event Description

Caregiver states the patient just got this unit on friday and the unit intermittently alarms while the patient is using it, caregiver also states the flow meter shows zero and when this happens the patient is not getting any oxygen, and the unit alarms.Caregiver states the consumer is currently in the hospital with symptoms of shortness of breath.Caregiver states that the consumer has alternative oxygen tanks to use but chose not to switch over to a tank when the concentrator showed problems.No additional information provided.Update from consumer affairs on 4/14/16: end user was hospitalized to be monitored due to the shortness of breath.No further information provided.

• Brand Name: PERFECTO2 OXYGEN CONCENTRATOR 9153646962
• 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: 5583901
• MDR Text Key: 42854572
• Report Number: 1031452-2016-01524
• 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
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• 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): Hospitalization