MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2V

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

There is no evidence to reasonably suggest the concentrator malfunctioned in the death of the end user.The end user failed to follow safety guidelines and repeated warnings not to smoke while using the concentrator.Per user manual 1193323-a, page 9 danger risk of death, injury, or damage from fire.To avoid fire, death, injury or damage: do not smoke while using this device.Do not use near open flame or ignition sources.Do not use any lubricants on concentrator unless recommended by invacare.No smoking signs should be prominently displayed.Avoid creation of any spark near oxygen equipment.This includes sparks from static electricity created by any type of friction.Keep all matches, lighted cigarettes, electronic cigarettes or other sources of ignition out of the room in which this concentrator is located and away from where oxygen is being delivered.Keep the oxygen tubing, cord, and concentrator out from under such items as blankets, bed coverings, chair cushions, clothing, and away from heated or hot surfaces including space heaters, stoves, and similar electrical appliances.Should additional information become available a supplemental record will be filed.

Event Description

The secretary of the crossroads hospice related the following information concerning the reported death, she related there was no further investigation on their end because the end user was warned over and over to not smoke while using the concentrator and the end user didn't care and smoked while on oxygen anyways.She stated ¿there was no doubt smoking with the oxygen was the cause of the fire and the family knew it was the cause and had been an ongoing issue¿¿.The secretary also stated, ¿to our knowledge, nothing was salvageable and i assume was discarded by homeowner or fire dept'.Therefore, there will not be a return.

• Brand Name: PERFECTO2 V WITH SENSOR 9153650799
• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6184804
• MDR Text Key: 63074707
• Report Number: 1031452-2016-03652
• 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
• Report Date: 12/07/2016

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: IRC5PO2V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/19/2016
• 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