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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 (1670)
Patient Problem Burn(s) (1757)
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.
 
Manufacturer Narrative
Invacare attended a conference call with the provider.Invacare again requested details regarding the patient's injury and death.The provider advised that the only information they were given was that the patient had severe burns to his face and esophagus.The patient's medical records were requested.The provider advised that none were available.Any medical treatment that the patient may have received is still unknown.The provider was also asked for a copy of the patient's death certificate or cause of death.The provider advised that they had requested this information, but it was not provided to them.The patient's cause of death remains unknown.The provider was asked to return the concentrator to invacare for inspection.They stated that, per their policy, they are keeping the unit in quarantine and will not return it to invacare.The provider did send a copy of the equipment check that they had performed on (b)(6) 2019, which shows that the concentrator was operating properly at that time.This additional information supports the initial findings that the concentrator contributed to a serious injury but that the incident was a result of use error and not a device deficiency.
 
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 Name
INVACARE PERFECTO2 V OXYGEN CONCENTRATOR
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA
2101 east lake mary blvd
sanford FL 32773
MDR Report Key8915649
MDR Text Key155046641
Report Number1031452-2019-00023
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
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
Was the Report Sent to FDA? No
Date Manufacturer Received09/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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