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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN CYLINDER OXYGEN M9 FOR CANADA W/INTEGRATED POST VALVE 9153653237 GENERATOR, OXYGEN, PORTABLE

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UNKNOWN CYLINDER OXYGEN M9 FOR CANADA W/INTEGRATED POST VALVE 9153653237 GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number UNKNOWN
Device Problems False Reading From Device Non-Compliance; Defective Device
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

Reporter states the defects include the oxygen tanks were empty or contained less oxygen than was represented. Reporter alleges the patient became anoxic and later died.

 
Manufacturer Narrative

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

 
Event Description

Update from (b)(6) 2015: invacare received additional information reporting the date of loss was (b)(6) 2013. Reporter states the defects include the oxygen tanks were empty or contained less oxygen than was represented. Reporter alleges the patient became anoxic and later died.

 
Manufacturer Narrative

This record is being filed due to follow up #2 submitted on 12/4/15 was inadvertently submitted as follow up #3 in error.

 
Event Description

Reporter states the defects include the oxygen tanks were empty or contained less oxygen than was represented. Reporter alleges the patient became anoxic and later died.

 
Manufacturer Narrative

Not an invacare product; (b)(6). Should additional information become available a supplemental record will be filed.

 
Event Description

Update from 11/19/2015: lawyer representing invacare provided product information from the dealer, american home patient. It shows the only invacare product provided to the patient was an (b)(6) (b)(4). No evidence a homefill was provided. The o2 tank conserving device was from (b)(6). In short, no evidence of an invacare product filling oxygen tanks or measuring the amount of o2 in a tank. There also continues to be no allegation the invacare concentrator malfunctioned. Update from 10/19/2015: invacare received additional information reporting the date of loss was (b)(4) 2013. Reporter states the defects include the oxygen tanks were empty or contained less oxygen than was represented. Reporter alleges the patient became anoxic and later died.

 
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Brand NameCYLINDER OXYGEN M9 FOR CANADA W/INTEGRATED POST VALVE 9153653237
Type of DeviceGENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
UNKNOWN
OH
Manufacturer (Section G)
UNKNOWN
OH
Manufacturer Contact
kevin guyton
one invacare way
elyria , OH 44036
8003336900
MDR Report Key5155557
Report Number1525712-2015-04919
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup
Report Date 11/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/16/2015 Patient Sequence Number: 1
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