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Model Number NA:IRC5PO2V |
Device Problems
Fire (1245); Sparking (2595); Explosion (4006)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This incident is being reported to the fda based on the evidence that the device experienced an over-pressurization event of the product tank, an overheating event, or a possible precursor to such events.Based on the pictures received this failure mode resembles that which has been previously identified and investigated.Components of the irc5po2v concentrator have been updated to prevent potential recurrence of this issue.The subject concentrator was manufactured prior to implementation of these updates.This issue also resulted in a field correction (z-0514-2021) to replace the pe valve assembly in impacted irc5po2v concentrators to reduce the potential for a failure that can, in infrequent instances, result in a short duration and self-extinguishing thermal reaction.The subject concentrator falls within the scope of this field correction.The device is awaiting return for further evaluation.This device was over 4 years old at the time of this incident which is past the 3-year service life listed in the manual.If a different root cause is determined, a supplemental record will be filed.
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Event Description
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The reporter states the device experienced sparking, explosion, and flames.No one was injured and no property damage occurred.
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Manufacturer Narrative
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Further information was gathered regarding this incident.The reporter clarified the fire that occurred went out immediately with no intervention.The device has been returned and is awaiting further evaluation.Once further information becomes available a follow up report will be filed if a different root cause is determined then what was reported in the initial medwatch.
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Event Description
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The reporter states the device experienced sparking, explosion, and flames.No one was injured and no property damage occurred.
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Search Alerts/Recalls
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