Model Number 3100A |
Device Problems
Break (1069); Pressure Problem (3012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/28/2014 |
Event Type
malfunction
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Manufacturer Narrative
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This medwatch report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.When the needle valve has been received and evaluated a supplement report will be filed to provide that detail.
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Event Description
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The following description of the event was documented by a carefusion tech support specialist in a response to a phone conversation with a user facility representative on (b)(6) 2014.The customer called to order a needle valve.They state that the old needle valve on the unit seemed to be damaged / broken.They installed a new needle valve and it passes the circuit calibration and all the pneumatics calibrations come into specification, but it seems to be very sensitive to movement.When they turn the knob to about the 12 o'clock position the unit seems to dump pressure.He is requesting a replacement needle valve.
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Manufacturer Narrative
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Failure analysis (fa) lab received a 3100a needle valve assy.The fa lab performed an investigation and was unable to duplicate the reported issue.
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Search Alerts/Recalls
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