Model Number UHI-4 |
Device Problems
Erratic or Intermittent Display (1182); Gas/Air Leak (2946); Infusion or Flow Problem (2964)
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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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The subject device was returned to (b)(4).(b)(4) checked the subject device and found that the reported phenomenon was duplicated due to the failure of the electrical circuit board.During the incoming inspection for repair of the subject device at (b)(4), it was also found the following.Flow rate check was not good due to defective manifold unit.Moisture came from the first regulator unit.Leakage came from the connector unit.The exact cause of the reported events could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during unspecified timing, it was found that the front panel leds of the subject device blinked.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. the exact cause of the reported event could not be conclusively determined.However, based on the reported information, omsc presumed that the cause of the phenomenon was the failure of the main board.The cause of the failure of the main board could not be conclusively determined. the exact cause of the reported event could not be conclusively determined.However, based on the reported information, omsc presumed that the cause of the phenomenon was the failure of the manifold unit.The cause of the failure of the manifold unit could not be conclusively determined. the exact cause of the reported event could not be conclusively determined. based on the reported information, omsc presumed that the cause of the phenomenon was the broken connector.The cause of the broken connector could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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