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U.S. Department of Health and Human Services

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

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INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problems Concentrator; Break; Thermal Decomposition of Device; Fire
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Reporter advised end user stated concentrator caught fire and damaged their carpet. Reporter could not advise how fire was put out. Reporter noticed a long burn mark on carpet where cannula would have been sitting. Reporter advised dealer stated thinks issue occurred due to family smokes and the filters are black. Reporter advised no injury. Reporter could not provide any end user information or any further information.

 
Manufacturer Narrative

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

 
Event Description

Update from 01/25/2016 10:17 am added by consumer affairs: dealer stated looked at the concentrator and the filter was black like they had smoked with the unit. Dealer states the floor in the house down the hallway to the unit is black from the outlet on the concentrator down the cannula all the way to the unit like they pulled the cannula off to smoke and the o2 came in contact with the flame. No alleged injury. No further information provided at this time. Update from 01/25/2016 03:50 pm added by consumer affairs: end user boyfriend stated no one smokes in the home and he doesn't know how it happened. End user boyfriend heard end user yelling from the living room and ran in there and she was trying to put out the fire with a pillow. End user boyfriend said there were foot high flames on the carpet going down the cannula. No injury. Damage to carpet, her chair, and end table. Reporter advised enduser stated concentrator caught fire and damaged their carpet. Reporter could not advise how fire was put out. Reporter noticed a long burn mark on carpet where cannula would have been sitting. Reporter advised dealer stated thinks issue occurred due to family smokes and the filters are black. Reporter advised no injury. Reporter could not provide any enduser information or any further information.

 
Manufacturer Narrative

Product was returned for evaluation. The return fields in oracle state: stationary concentrators. Other, hold for detailed evaluation. Product received expanded evaluation. The expanded evaluation report states: visual inspection- the cabinet was received with a large burn mark on the front face and neat the outlet port. The inside of the cabinet was free from any fire damage but was covered in white sieve dust. The lack of any fire damage inside of the cabinet suggests that the fire started at a source outside of the concentrator. Hair accumulations were also present inside of the cabinet. Conclusions - utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was not confirmed for the concentrator catching on fire. Fire damage was present only to the outside of the concentrator, not inside of the cabinet. This suggests that the source of the fire was outside of the unit. Complaint was not confirmed. The underlying cause is external source of fire. Root cause could not be determined after reviewing the documentation in this investigation. User¿s manual review 1143482 rev. F. (page 4) danger - do not smoke while using this device. Keep all matches, lighted cigarettes or other sources of ignition out of the room in which this product is located and away from where oxygen is being delivered. No smoking signs should be prominently displayed. Textiles and other materials that normally would not burn are easily ignited and burn with great intensity in oxygen enriched air. Failure to observe this warning can result in severe fire, property damage and cause physical injury or death. (page 22) note: at a minimum, preventive maintenance must be performed according to the maintenance record guidelines. In places with high dust or soot levels, maintenance may need to be performed more often.

 
Event Description

Product was returned for evaluation. The return fields in oracle state: stationary concentrators. Other, hold for detailed evaluation. Product received expanded evaluation. The expanded evaluation report states: visual inspection- the cabinet was received with a large burn mark on the front face and neat the outlet port. The inside of the cabinet was free from any fire damage but was covered in white sieve dust. The lack of any fire damage inside of the cabinet suggests that the fire started at a source outside of the concentrator. Hair accumulations were also present inside of the cabinet. Conclusions - utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was not confirmed for the concentrator catching on fire. Fire damage was present only to the outside of the concentrator, not inside of the cabinet. This suggests that the source of the fire was outside of the unit. Update from 01/25/2016 10:17 am added by consumer affairs: dealer stated looked at the concentrator and the filter was black like they had smoked with the unit. Dealer states the floor in the house down the hallway to the unit is black from the outlet on the concentrator down the cannula all the way to the unit like they pulled the cannula off to smoke and the o2 came in contact with the flame. No alleged injury. No further information provided at this time. Update from 01/25/2016 03:50 pm added by consumer affairs: end user boyfriend stated no one smokes in the home and he doesn't know how it happened. End user boyfriend heard end user yelling from the living room and ran in there and she was trying to put out the fire with a pillow. End user boyfriend said there were foot high flames on the carpet going down the cannula. No injury. Damage to carpet, her chair, and end table. Reporter advised enduser stated concentrator caught fire and damaged their carpet. Reporter could not advise how fire was put out. Reporter noticed a long burn mark on carpet where cannula would have been sitting. Reporter advised dealer stated thinks issue occurred due to family smokes and the filters are black. Reporter advised no injury. Reporter could not provide any enduser information or any further information.

 
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Brand NamePERFECTO2 V WITH SENSOR 9153650799
Type of DeviceGENERATOR, 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 Key5387898
Report Number1031452-2016-00302
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup,Followup
Report Date 03/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC5PO2V
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2016
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

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