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

Model Number UNKNOWN

Device Problems False Reading From Device Non-Compliance (1228); Defective Device (2588)

Patient Problems Anoxia (1711); Death (1802)

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.

• Brand Name: CYLINDER OXYGEN M9 FOR CANADA W/INTEGRATED POST VALVE 9153653237
• Type of Device: GENERATOR, 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 Key: 5155557
• MDR Text Key: 28445083
• Report Number: 1525712-2015-04919
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Followup,Followup,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death