SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problems
Device Alarm System (1012); Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that there was an error code 2 found when they turned it on, and it kept beeping.There was no patient involvement and no patient harm/adverse event reported.
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Manufacturer Narrative
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Date of event is unknown; no information has been provided to date.Device 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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Search Alerts/Recalls
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