Model Number 1054655 |
Device Problems
Contamination (1120); Mechanical Problem (1384); Failure to Recalibrate (1517)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2021 |
Event Type
malfunction
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Event Description
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A ventilator was returned to the manufacturer for service.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, an issue related to the device's overhead blower filter was observed.The device's overhead blower filter needs replaced to address the issue.There was evidence of contamination.
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Manufacturer Narrative
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The manufacture previously reported an issue related to a ventilator's overhead blower filter was observed and the overhead blower filter needed replaced to address the issue.During additional testing, the device failed a test step.The device was recalibrated to address the issue.
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Manufacturer Narrative
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The manufacturer previously reported sections b.3 and g.3 with an incorrect date of 04/07/2021.The correct date should be 04/26/2021.Section g2: was incorrectly reported as "foreign-user facility".The correct response is "foreign-company representative." section e1: initial reported was incorrect.The correct reporter is hisae ino.Section e4 was marked as "unknown" and should have been marked "no".All correct responses are reflected in this report.
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Search Alerts/Recalls
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