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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE PLATINUM XL 101; 10 LPM O2 CONCENTRATOR
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INVACARE PLATINUM XL 101; 10 LPM O2 CONCENTRATOR Back to Search Results
Model Number IRC10LX02
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Respiratory Distress (2045); Partial thickness (Second Degree) Burn (2694)
Event Date 06/25/2018
Event Type  Death  
Event Description
Per report of (b)(6)'s spouse on (b)(6) 2018 at 1:22am, pt lit a cigarette and "blew up his oxygen." pt 911'd to local hospital where he was found to have sustained 2nd degree burns to his face, smoke inhalation, and exacerbation of copd.On (b)(6) 2018, (b)(6) was then transferred to a tertiary hospital in an adjoining county where medical records indicate acute respiratory insufficiency, and partial thickness burns of right cheek, left cheek, nose, and lip.On (b)(6) 2018 pt was admitted to a hospice inpatient unit at that hospital where he was reported to have died on (b)(6) 2018.
 
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Brand Name
PLATINUM XL 101
Type of Device
10 LPM O2 CONCENTRATOR
Manufacturer (Section D)
INVACARE
one invacare way
elyria OH 44036 2125
MDR Report Key7677083
MDR Text Key113754002
Report Number7677083
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 Other
Type of Report Initial
Report Date 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberIRC10LX02
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/05/2018
Distributor Facility Aware Date06/25/2018
Device Age67 MO
Event Location Home
Date Report to Manufacturer07/05/2018
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
Patient Outcome(s) Death; Hospitalization;
Patient Age64 YR
Patient Weight45
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