Model Number UNKNOWN |
Device Problems
False Reading From Device Non-Compliance (1228); Defective Device (2588)
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Patient Problems
Anoxia (1711); Death (1802)
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Event Type
Death
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Manufacturer Narrative
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Should additional information become available a supplemental record will be filed.
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Event Description
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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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Manufacturer Narrative
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Should additional information become available a supplemental record will be filed.
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Event Description
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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.
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Manufacturer Narrative
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This record is being filed due to follow up #2 submitted on 12/4/15 was inadvertently submitted as follow up #3 in error.
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Event Description
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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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Manufacturer Narrative
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Not an invacare product; (b)(6).Should additional information become available a supplemental record will be filed.
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Event Description
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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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Search Alerts/Recalls
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