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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRSEP (CAIRE) INTENSITY; O2 CONCENTRATOR
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AIRSEP (CAIRE) INTENSITY; O2 CONCENTRATOR Back to Search Results
Model Number AS099-101
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Injury (2348); Full thickness (Third Degree) Burn (2696)
Event Date 04/18/2019
Event Type  Injury  
Event Description
Pt was smoking while using oxygen, causing a fire and the pt to sustain third degree burns on his face, in his nares, left armpit and on his left side.He took himself to the urgent care center for treatment and returned home with silvadene cream treatment to the burns.
 
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Brand Name
INTENSITY
Type of Device
O2 CONCENTRATOR
Manufacturer (Section D)
AIRSEP (CAIRE)
2205 airport ind. drive
ball ground GA
MDR Report Key8616945
MDR Text Key145281868
Report Number8616945
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
Device Model NumberAS099-101
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/15/2019
Distributor Facility Aware Date04/18/2019
Device Age2 MO
Event Location Home
Date Report to Manufacturer05/15/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/15/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
22" WHEELCHAIR ; BIPAP ST ; CONCERVING DEVICE W/M6 TANK ; M CYLINDER; M6 CYLINDER; M6 CYLINDERS; NEBULIZER; O2 CONCENTRATOR
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight117
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