Catalog Number 21-2120-0105-01 |
Device Problems
Failure to Power Up (1476); Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the cassette was not properly attached and was reattached with the tubing clamped.Unlatched battery door, as silver bar was locked.The door was left open for 1 minute and tightened.Pump would not power on.They tried 3 times and installed new batteries.Came on for one second and screen went blank again.This occurred at the patient's home and was operated by a health professional.There was patient involvement and no harm/adverse event reported.
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Search Alerts/Recalls
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