MAUDE Adverse Event Report: UNKNOWN PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn(s) (1757)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation from an expert hired by (b)(6) states that light microscopy and 3d x-ray computed tomography was used to identify a failed capacitor internal to the concentrator, which they believe was the cause of the fire.The report claims that the capacitor showed signs of expansion and bulging.Invacare has not yet been permitted to confirm this allegation.The expert report states the oxygen concentrator was plugged into a power strip, but it does not state whether the concentrator was turned on at the time of the incident.The lawyer's office was contacted to acknowledge receipt of the letter and to learn more about this incident.The serial number of the concentrator was requested, but the law office did not provide it.On 04/09/2019, the fire department incident report was received.It states that the cause of ignition is undetermined after investigation.The material first ignited and contributing most to flame spread was determined to be the bedding material (blanket, sheet, comforter).The fire report gives the following account of events: the patient said she was sleeping in bed when she awoke to fire at the foot of her bed.She said that she tried to put the fire out by swatting it with her hands.She sustained small second degree burns to one of her hands and was treated at the scene and transported to the hospital by ems.Her husband was sleeping in the living room on the couch.When he woke up, he assisted her out of the house.The patient said that she usually smokes in bed, so it could be a possibility that a cigarette started the fire.In the fire origin there was also an electrical outlet with items plugged into it.The fire report indicated that they were unable to definitively determine the cause of the fire.Photographs of the loss site were provided by the (b)(6) representative.One of the photos, taken on (b)(6) 2017, showed the oxygen concentrator, which displayed discoloration/destruction that is consistent with thermal damage.It cannot be determined from the photograph whether the fire originated internally or external to the device.This event is being reported to the fda in an abundance of caution.Although the cause of the fire is undetermined, it cannot be ruled out that the concentrator potentially caused/contributed to the event.At this time, invacare has not been permitted to evaluate the concentrator.Additionally, no further details regarding the patient's injury have been provided.It is unknown what medical treatment the patient received at the scene or following transport to the hospital.Should additional information become available, a supplemental record will be filed.The irc5po2 concentrator has been obsolete.It was previously manufactured by invacare (b)(4) and invacare rehabilitation equipment co.((b)(4)).Since the serial number of the concentrator is not available, it cannot be determined which of these sites manufactured the subject concentrator.(b)(4) is no longer an active manufacturing facility, so the mdr is being filed using invacare (b)(4) cfn.

Event Description

Invacare received a letter from a lawyer representing (b)(6) insurance.The letter stated that a fire occurred at the home of their insured.The letter indicated that the fire originated at the foot of the patient's bed, and an invacare irc5po2 concentrator was located in the area of the fire.

Manufacturer Narrative

Invacare's lawyer and expert attended an inspection of the concentrator.(b)(6) expert had previously indicated that the capacitor inside the concentrator had failed and that they believed this was the cause of the fire.However, it was determined that the failed capacitor actually came from a television, not the invacare concentrator.Invacare's expert found that the concentrator's capacitor was undamaged, with no evidence that it caused or contributed to the fire.In addition, the expert also indicated that the fire appeared to travel downward from the top of the concentrator, which is not consistent with a fire that originated within the concentrator.Based on the available information, it appears that the concentrator sustained damaged from a fire that originated external to the device.The concentrator itself did not cause the fire.

Event Description

Invacare received a letter from a lawyer representing (b)(6) insurance.The letter stated that a fire occurred at the home of their insured.The letter indicated that the fire originated at the foot of the patient's bed, and an invacare irc5po2 concentrator was located in the area of the fire.

• Brand Name: PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): UNKNOWN
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8545389
• MDR Text Key: 142937366
• Report Number: 1031452-2019-00010
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5PO2
• Device Catalogue Number: IRC5PO2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 07/24/2019
• 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
• Patient Age: 61 YR