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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE

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INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problem Use of Device Problem
Event Date 03/01/2019
Event Type  Injury  
Manufacturer Narrative

This incident is being reported due to the allegation that the patient was sent to a burn center for his injury. At this time, there is not enough information to suggest that the concentrator contributed to the patient's death. The severity of the injury and specific treatment received is unknown. Details of the patient's death (date, cause, etc. ) are also unknown. This information has been requested but not provided. There was no alleged malfunction/deficiency with the device. Based on the available information, the event was a result of use error; the patient did not adhere to the device labeling and instructions. The irc5po2v user manual states, "do not smoke while using this device. Do not use near open flame or ignition sources. No smoking signs should be prominently displayed. 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. " in addition, the device itself is prominently labeled regarding the hazard of smoking or exposing the unit to an open flame/ignition source. Should additional information become available, a supplemental record will be filed.

 
Event Description

The provider reported that a family member of the patient alleged that the patient was smoking while using the irc5po2v concentrator. The patient reportedly sustained burns from the incident and was transported to a burn center. The family member stated that the patient has since expired.

 
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Brand NameINVACARE PERFECTO2 V OXYGEN CONCENTRATOR
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA
2101 east lake mary blvd
sanford FL 32773
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 Key8915649
Report Number1031452-2019-00023
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberIRC5PO2V
Device Catalogue NumberIRC5PO2V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/21/2019 Patient Sequence Number: 1
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